GenVec, Inc. (Nasdaq:GNVC) announced that it has received a Small Business Innovation and Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) to support the company's malaria vaccine program. This grant, valued at approximately $600,000 over two years, will be used to develop enhancements to the company's vectors for vaccine applications against malaria.
GenVec is applying its adenovector technology to the development of malaria vaccine candidates in collaboration with the U.S. Naval Medical Research Center (NMRC) and PATH's Malaria Vaccine Initiative. The NMRC is currently conducting a Phase I/II clinical study to assess the safety and immunogenicity of a vaccine candidate developed under this program.
"In addition to advancing our malaria vaccine program, work under this grant may provide improvements to our technology that could be applied to other adenovector-based vaccines and therapeutics," said Dr. Rick King, GenVec's Senior Vice President of Research.
About GenVec
GenVec, Inc. is a biopharmaceutical company developing novel therapeutic drugs and vaccines. GenVec's lead product, TNFerade™, is currently in a pivotal clinical study (PACT) in locally advanced pancreatic cancer. Additional clinical trials are in progress in rectal cancer, head and neck cancer and melanoma. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV, malaria, foot-and-mouth disease, respiratory syncytial virus (RSV), and influenza. Additional information about GenVec is available at http://www.genvec.com and in the company's various filings with the Securities and Exchange Commission.
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future revenues and operating expenses, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by GenVec to secure and maintain relationships with collaborators; risks relating to the early stage of GenVec's product candidates under development; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of GenVec's proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations, are contained in GenVec's filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. These forward-looking statements speak only as of the date of this press release, and GenVec assumes no duty to update forward-looking statements.
GenVec
Monday, April 7, 2008
Taro Receives Tentative FDA Approval For Lamotrigine Tablets ANDA
Taro Pharmaceutical Industries Ltd. ("Taro," the "Company," Pink Sheets: TAROF) reported today that it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Lamotrigine Tablets 25 mg, 100 mg, 150 mg, and 200 mg ("Lamotrigine Tablets").
Lamotrigine is a prescription product used for the treatment of seizures and is bioequivalent to GlaxoSmithKline's Lamictal® Tablets. According to industry sources, Lamictal® Tablets had annual U.S. sales of approximately $2.6 billion.
The tentative ANDA approval for Taro's Lamotrigine Tablets is an FDA determination that Taro's ANDA submission for this product currently satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities and restrictions (currently expected to occur during January 2009), or any new information that may come to the FDA's attention. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission.
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.
For further information on Taro Pharmaceutical Industries Ltd., please visit the Company's website at http://www.taro.com.
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's lamotrigine product. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include failure to receive final approval for Taro's ANDA submission for Lamotrigine Tablets; the granting of additional exclusivities or restrictions to Lamictal® Tablets; industry and market conditions; slower than anticipated penetration of new markets; physician, pharmacist or patient acceptance of Taro's Lamotrigine Tablets; changes in the Company's financial position; regulatory actions; and, other risks detailed from time to time in the Company's SEC reports, including its Annual Reports on Form 20-F. Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to update, change or revise any forward-looking statements, whether as a result of new information, additional or subsequent developments or otherwise.
Taro Pharmaceutical Industries Ltd.
Lamotrigine is a prescription product used for the treatment of seizures and is bioequivalent to GlaxoSmithKline's Lamictal® Tablets. According to industry sources, Lamictal® Tablets had annual U.S. sales of approximately $2.6 billion.
The tentative ANDA approval for Taro's Lamotrigine Tablets is an FDA determination that Taro's ANDA submission for this product currently satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities and restrictions (currently expected to occur during January 2009), or any new information that may come to the FDA's attention. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission.
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.
For further information on Taro Pharmaceutical Industries Ltd., please visit the Company's website at http://www.taro.com.
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's lamotrigine product. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include failure to receive final approval for Taro's ANDA submission for Lamotrigine Tablets; the granting of additional exclusivities or restrictions to Lamictal® Tablets; industry and market conditions; slower than anticipated penetration of new markets; physician, pharmacist or patient acceptance of Taro's Lamotrigine Tablets; changes in the Company's financial position; regulatory actions; and, other risks detailed from time to time in the Company's SEC reports, including its Annual Reports on Form 20-F. Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to update, change or revise any forward-looking statements, whether as a result of new information, additional or subsequent developments or otherwise.
Taro Pharmaceutical Industries Ltd.
FDA Approves ROTARIX(R) Rotavirus Vaccine
AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) announced that its partner, GlaxoSmithKline (GSK), has received approval from the U.S. Food and Drug Administration (FDA) for ROTARIX® for the prevention of rotavirus gastroenteritis in infants. With only two doses, ROTARIX will offer protection against the most commonly circulating rotavirus types in the U.S. and allow infants to complete the vaccination series by four months of age. The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that children complete the rotavirus immunization series by six months of age. Rotavirus infects virtually every child in the United States by age five and is the leading cause of severe gastroenteritis in infants and young children worldwide. ROTARIX may help prevent many of the 55,000 - 70,000 hospitalizations by young children that result from rotavirus in the U.S. each year.
Not only does ROTARIX confer protection at an early age, but clinical trials have shown that protection is broad and sustained. ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a two-dose series in infants and children. Clinical data published on the two-dose series of ROTARIX show that protection was sustained through the first two years of life and was highly efficacious against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%). In addition, ROTARIX was effective against rotavirus gastroenteritis of any severity (79%). Specifically, significant protection was demonstrated against severe rotavirus gastroenteritis during two rotavirus seasons caused by types G1 (96%), G2 (86%), G3 (94%), G4 (95%), and G9 (85%), the most commonly circulating rotavirus types in the U.S.
"We are delighted that our partner GSK has received approval of ROTARIX in the United States," said Una S. Ryan, Ph.D., President and Chief Executive Officer of AVANT Immunotherapeutics. "With only two doses, ROTARIX will allow infants to complete the vaccination series against rotavirus earlier than ever before. We have great expectations for GSK to launch ROTARIX prior to the upcoming rotavirus season."
AVANT licensed the technology for ROTARIX to GSK in 1997 for worldwide commercialization. The vaccine was originally developed at Cincinnati Children's Hospital Medical Center. The FDA's approval of ROTARIX was based on one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants. These clinical trials were conducted in the Americas, Europe, Asia and Africa and reflect an ethnically diverse population.
About ROTARIX
ROTARIX is an oral live-attenuated human rotavirus vaccine licensed in more than 100 countries around the world. More than 25 million doses of ROTARIX have been distributed worldwide. The vaccine was developed for the prevention of rotavirus gastroenteritis by mimicking the protective effects of natural human rotavirus infection. Naturally occurring human rotavirus infection provides significant protection against subsequent moderate to severe rotavirus gastroenteritis regardless of the infecting serotype(s). Five Phase 3 clinical trials were conducted worldwide to assess the safety and efficacy of ROTARIX in support of U.S. licensure. The clinical trials conducted in support of U.S. licensure demonstrated efficacy against rotavirus gastroenteritis of any severity due to the most common currently circulating rotavirus types in the U.S. In clinical studies, common adverse events were fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting. ROTARIX is contraindicated in certain individuals with a history of uncorrected congenital malformation of the gastrointestinal tract.
About Rotavirus
Rotavirus infects virtually every child worldwide by age five and is the leading cause of severe gastroenteritis in infants and young children in the U.S. and worldwide. Severe, dehydrating gastroenteritis can occur as young as three months of age. In the U.S. each year, 2.7 million children younger than five years of age suffer from rotavirus disease, resulting in 410,000 clinic visits and up to 272,000 emergency department visits. In addition, between 55,000 and 70,000 children are hospitalized and 20 to 60 die each year. In the U.S., the rotavirus season typically begins in the southwest during November-December and spreads to the northeast by April-May.
About GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GlaxoSmithKline Biologicals (GSK Biologicals) is a global vaccine company which has shown to be a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 14 manufacturing sites strategically positioned around the globe. In 2007 GSK Biologicals distributed 1.1 billion doses of vaccines to 169 countries in both developed and the developing world -- an average of 3 million doses a day.
GSK Biologicals employs over 9,000 people worldwide including more than 1,600 passionate scientists engaged in research aimed at discovering innovative vaccines that contribute to the health and well-being of people of all generations around the world.
About AVANT Immunotherapeutics, Inc.
AVANT Immunotherapeutics, Inc. is a NASDAQ-listed company discovering and developing innovative vaccines and targeted immunotherapeutics for the treatment of cancer, infectious and inflammatory diseases. AVANT focuses on the use of tumor-specific targets and human monoclonal antibodies (mAbs) to precisely deliver therapeutic agents through its novel "targeted immunization" approach. AVANT also possesses innovative bacterial vector delivery technologies with unique manufacturing and preservation processes that offer the potential for a new generation of infectious disease vaccines. AVANT's deep product pipeline consists of products in varying stages of development, with its lead candidate, CDX-110, currently undergoing evaluation in a Phase 2/3 clinical trial in newly diagnosed glioblastoma multiforme, one of the most aggressive forms of brain cancer. AVANT also has five product candidates in its development pipeline including:
- CDX-1307, a product based on its proprietary APC Targeting Technology™, which is in two Phase 1 clinical trials for patients with advanced pancreatic, bladder, breast and colon cancer;
- a complement inhibitor, TP10, in development for transplantation and other indications; and
- three candidates based on its oral, rapidly-protecting, single-dose and temperature-stable vaccine technology, including combination vaccines for travelers, the military and global health needs.
AVANT has three commercialized products, including ROTARIX for the prevention of rotavirus infection and two human food safety vaccines for reducing salmonella infection in chickens and eggs.
AVANT Immunotherapeutics, Inc.
Not only does ROTARIX confer protection at an early age, but clinical trials have shown that protection is broad and sustained. ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a two-dose series in infants and children. Clinical data published on the two-dose series of ROTARIX show that protection was sustained through the first two years of life and was highly efficacious against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%). In addition, ROTARIX was effective against rotavirus gastroenteritis of any severity (79%). Specifically, significant protection was demonstrated against severe rotavirus gastroenteritis during two rotavirus seasons caused by types G1 (96%), G2 (86%), G3 (94%), G4 (95%), and G9 (85%), the most commonly circulating rotavirus types in the U.S.
"We are delighted that our partner GSK has received approval of ROTARIX in the United States," said Una S. Ryan, Ph.D., President and Chief Executive Officer of AVANT Immunotherapeutics. "With only two doses, ROTARIX will allow infants to complete the vaccination series against rotavirus earlier than ever before. We have great expectations for GSK to launch ROTARIX prior to the upcoming rotavirus season."
AVANT licensed the technology for ROTARIX to GSK in 1997 for worldwide commercialization. The vaccine was originally developed at Cincinnati Children's Hospital Medical Center. The FDA's approval of ROTARIX was based on one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants. These clinical trials were conducted in the Americas, Europe, Asia and Africa and reflect an ethnically diverse population.
About ROTARIX
ROTARIX is an oral live-attenuated human rotavirus vaccine licensed in more than 100 countries around the world. More than 25 million doses of ROTARIX have been distributed worldwide. The vaccine was developed for the prevention of rotavirus gastroenteritis by mimicking the protective effects of natural human rotavirus infection. Naturally occurring human rotavirus infection provides significant protection against subsequent moderate to severe rotavirus gastroenteritis regardless of the infecting serotype(s). Five Phase 3 clinical trials were conducted worldwide to assess the safety and efficacy of ROTARIX in support of U.S. licensure. The clinical trials conducted in support of U.S. licensure demonstrated efficacy against rotavirus gastroenteritis of any severity due to the most common currently circulating rotavirus types in the U.S. In clinical studies, common adverse events were fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting. ROTARIX is contraindicated in certain individuals with a history of uncorrected congenital malformation of the gastrointestinal tract.
About Rotavirus
Rotavirus infects virtually every child worldwide by age five and is the leading cause of severe gastroenteritis in infants and young children in the U.S. and worldwide. Severe, dehydrating gastroenteritis can occur as young as three months of age. In the U.S. each year, 2.7 million children younger than five years of age suffer from rotavirus disease, resulting in 410,000 clinic visits and up to 272,000 emergency department visits. In addition, between 55,000 and 70,000 children are hospitalized and 20 to 60 die each year. In the U.S., the rotavirus season typically begins in the southwest during November-December and spreads to the northeast by April-May.
About GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GlaxoSmithKline Biologicals (GSK Biologicals) is a global vaccine company which has shown to be a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 14 manufacturing sites strategically positioned around the globe. In 2007 GSK Biologicals distributed 1.1 billion doses of vaccines to 169 countries in both developed and the developing world -- an average of 3 million doses a day.
GSK Biologicals employs over 9,000 people worldwide including more than 1,600 passionate scientists engaged in research aimed at discovering innovative vaccines that contribute to the health and well-being of people of all generations around the world.
About AVANT Immunotherapeutics, Inc.
AVANT Immunotherapeutics, Inc. is a NASDAQ-listed company discovering and developing innovative vaccines and targeted immunotherapeutics for the treatment of cancer, infectious and inflammatory diseases. AVANT focuses on the use of tumor-specific targets and human monoclonal antibodies (mAbs) to precisely deliver therapeutic agents through its novel "targeted immunization" approach. AVANT also possesses innovative bacterial vector delivery technologies with unique manufacturing and preservation processes that offer the potential for a new generation of infectious disease vaccines. AVANT's deep product pipeline consists of products in varying stages of development, with its lead candidate, CDX-110, currently undergoing evaluation in a Phase 2/3 clinical trial in newly diagnosed glioblastoma multiforme, one of the most aggressive forms of brain cancer. AVANT also has five product candidates in its development pipeline including:
- CDX-1307, a product based on its proprietary APC Targeting Technology™, which is in two Phase 1 clinical trials for patients with advanced pancreatic, bladder, breast and colon cancer;
- a complement inhibitor, TP10, in development for transplantation and other indications; and
- three candidates based on its oral, rapidly-protecting, single-dose and temperature-stable vaccine technology, including combination vaccines for travelers, the military and global health needs.
AVANT has three commercialized products, including ROTARIX for the prevention of rotavirus infection and two human food safety vaccines for reducing salmonella infection in chickens and eggs.
AVANT Immunotherapeutics, Inc.
Carl Zeiss Meditec Delivers Key Technological Advances In Optical Coherence Tomography
Carl Zeiss Meditec, a leader in ophthalmic devices and surgical systems, announced today that two new optical coherence tomography (OCT) applications will be available for the first time at the American Society of Cataract and Refractive Surgeons (ASCRS) meeting in Chicago, IL at booth 2028. With advanced algorithms available for Cirrus™ HD-OCT and Stratus™ OCT, ophthalmologists now have the most advanced imaging capabilities available for assessing and managing glaucoma and diseases of the retina.
The Cirrus HD-OCT, the latest addition to the Zeiss OCT family of products, provides the most detailed scan patterns and layer maps available for identifying retinal and glaucoma disease characteristics, and monitoring disease progression. Nearly 1000 Cirrus HD-OCT units have been sold worldwide since its introduction last November. It is the first in its category to deliver high-definition 3D maps to spectral domain technology.
"The Cirrus HD-OCT 3-D images bring us a new level of insight into the detailed structure of the retina," said Peter K. Kaiser, MD, Director of the Clinical Research Center, Cole Eye Institute in Cleveland. "Combined with the proprietary image analysis algorithms developed by the veteran Zeiss team, the Cirrus gives us new volumetric data that expands our ability to interpret the three dimensional images in a highly reproducible, quantitative fashion."
For the first time, Stratus OCT features both Advanced Serial Analysis and Guided Progression Analysis™ (GPA) software for objective measurement and subjective clinical evaluation in the detection of glaucoma and retinal diseases. Advanced Serial Analysis plots RNFL thickness over time and reports statistically significant change, enabling practitioners to project future vision loss and make timely treatment decisions.
Stratus OCT is the standard of care system for comprehensive retinal scanning. With nearly 9,000 Stratus OCT units in use worldwide, more than 37,000 scans performed each year and backed by over 100 U.S. clinical studies for retinal disease, the Stratus OCT is the most widely adopted and researched OCT system in the world.
"From pioneering the first OCT platform nearly a decade ago to launching the newest Cirrus HD-OCT system late last year, Zeiss continues its tradition of leadership with spectral domain technology," said Jim Taylor, Carl Zeiss Meditec president and chief executive officer. "The new features for the Cirrus and Status OCT systems provide efficiencies that allow physicians to more easily gather and interpret detailed disease information while streamlining workflow processes that impact the entire practice. Our ultimate goal is to enable our customers to provide the best quality of care possible to their patients."
Optical coherence tomography (OCT) is an imaging method that uses light to scan the retina, and can be performed on undilated pupils as small as 3 mm in diameter. It provides detailed, real-time information about the structure of the living eye available to the clinician. Using light to scan the retina and optic disc, this pioneering technology brought new clinical tools for the diagnosis and management of retinal disease and glaucoma.
About Carl Zeiss Meditec
Carl Zeiss Meditec AG (ISIN: DE 0005313704) is one of the world's leading medical technology companies. This market position is based on over 160 years of experience in optical innovation.
The company has two primary areas of activity: In the field of ophthalmology Carl Zeiss Meditec offers integrated solutions for treating the four main eye ailments: vision defects (refraction), cataract, glaucoma and retinal disorders. The company's system solutions are employed in all phases of the disease management, from diagnosis to treatment and aftercare. Carl Zeiss Meditec has always applied its technological expertise to product innovations. These innovations range from basic systems such as slit lamps and fundus cameras to standard setting diagnostic systems such as the Humphrey® Field Analyzer, the Stratus OCT™ and the IOLMaster®, through to the surgical microscopes and innovative treatment systems in refractive laser surgery. The product portfolio in ophthalmic surgery is rounded off by intraocular lenses and consumables.
In the field of neuro and ENT surgery, Carl Zeiss Meditec is the world's leading provider of surgical microscopes and microsurgical visualization solutions for a very broad range of applications, such as tumor and vascular surgery in the head region and/or spinal surgery. The most recent example of the innovative performance in the area of microsurgery is the OPMI Pentero® visualization system, which allows efficient and ergonomic patient treatment. Carl Zeiss Meditec will systematically expand its product range in this area and become a solution provider in neuro and ENT surgery as well.
Carl Zeiss Meditec's medical technology portfolio is rounded off by visualization systems for doctors in private practice and promising future technologies such as intraoperative radiation therapy, which allows the targeted treatment of breast cancer and brain cancer directly during surgery.
Carl Zeiss Meditec AG is based in Jena, Germany, with subsidiaries in Germany (Carl Zeiss Surgical GmbH, Carl Zeiss Meditec Vertriebsgesellschaft mbH, *Acri.Tec AG and Carl Zeiss Medical Software GmbH), the USA (Carl Zeiss Meditec, Inc., Dublin), in Japan (Carl Zeiss Meditec Co., Ltd., Tokyo), Spain (Carl Zeiss Meditec Iberia S.A., Madrid) and France (Carl Zeiss Meditec S.A.S., La Rochelle, and Carl Zeiss Meditec France SAS, Le Pecq).
Carl Zeiss Meditec
The Cirrus HD-OCT, the latest addition to the Zeiss OCT family of products, provides the most detailed scan patterns and layer maps available for identifying retinal and glaucoma disease characteristics, and monitoring disease progression. Nearly 1000 Cirrus HD-OCT units have been sold worldwide since its introduction last November. It is the first in its category to deliver high-definition 3D maps to spectral domain technology.
"The Cirrus HD-OCT 3-D images bring us a new level of insight into the detailed structure of the retina," said Peter K. Kaiser, MD, Director of the Clinical Research Center, Cole Eye Institute in Cleveland. "Combined with the proprietary image analysis algorithms developed by the veteran Zeiss team, the Cirrus gives us new volumetric data that expands our ability to interpret the three dimensional images in a highly reproducible, quantitative fashion."
For the first time, Stratus OCT features both Advanced Serial Analysis and Guided Progression Analysis™ (GPA) software for objective measurement and subjective clinical evaluation in the detection of glaucoma and retinal diseases. Advanced Serial Analysis plots RNFL thickness over time and reports statistically significant change, enabling practitioners to project future vision loss and make timely treatment decisions.
Stratus OCT is the standard of care system for comprehensive retinal scanning. With nearly 9,000 Stratus OCT units in use worldwide, more than 37,000 scans performed each year and backed by over 100 U.S. clinical studies for retinal disease, the Stratus OCT is the most widely adopted and researched OCT system in the world.
"From pioneering the first OCT platform nearly a decade ago to launching the newest Cirrus HD-OCT system late last year, Zeiss continues its tradition of leadership with spectral domain technology," said Jim Taylor, Carl Zeiss Meditec president and chief executive officer. "The new features for the Cirrus and Status OCT systems provide efficiencies that allow physicians to more easily gather and interpret detailed disease information while streamlining workflow processes that impact the entire practice. Our ultimate goal is to enable our customers to provide the best quality of care possible to their patients."
Optical coherence tomography (OCT) is an imaging method that uses light to scan the retina, and can be performed on undilated pupils as small as 3 mm in diameter. It provides detailed, real-time information about the structure of the living eye available to the clinician. Using light to scan the retina and optic disc, this pioneering technology brought new clinical tools for the diagnosis and management of retinal disease and glaucoma.
About Carl Zeiss Meditec
Carl Zeiss Meditec AG (ISIN: DE 0005313704) is one of the world's leading medical technology companies. This market position is based on over 160 years of experience in optical innovation.
The company has two primary areas of activity: In the field of ophthalmology Carl Zeiss Meditec offers integrated solutions for treating the four main eye ailments: vision defects (refraction), cataract, glaucoma and retinal disorders. The company's system solutions are employed in all phases of the disease management, from diagnosis to treatment and aftercare. Carl Zeiss Meditec has always applied its technological expertise to product innovations. These innovations range from basic systems such as slit lamps and fundus cameras to standard setting diagnostic systems such as the Humphrey® Field Analyzer, the Stratus OCT™ and the IOLMaster®, through to the surgical microscopes and innovative treatment systems in refractive laser surgery. The product portfolio in ophthalmic surgery is rounded off by intraocular lenses and consumables.
In the field of neuro and ENT surgery, Carl Zeiss Meditec is the world's leading provider of surgical microscopes and microsurgical visualization solutions for a very broad range of applications, such as tumor and vascular surgery in the head region and/or spinal surgery. The most recent example of the innovative performance in the area of microsurgery is the OPMI Pentero® visualization system, which allows efficient and ergonomic patient treatment. Carl Zeiss Meditec will systematically expand its product range in this area and become a solution provider in neuro and ENT surgery as well.
Carl Zeiss Meditec's medical technology portfolio is rounded off by visualization systems for doctors in private practice and promising future technologies such as intraoperative radiation therapy, which allows the targeted treatment of breast cancer and brain cancer directly during surgery.
Carl Zeiss Meditec AG is based in Jena, Germany, with subsidiaries in Germany (Carl Zeiss Surgical GmbH, Carl Zeiss Meditec Vertriebsgesellschaft mbH, *Acri.Tec AG and Carl Zeiss Medical Software GmbH), the USA (Carl Zeiss Meditec, Inc., Dublin), in Japan (Carl Zeiss Meditec Co., Ltd., Tokyo), Spain (Carl Zeiss Meditec Iberia S.A., Madrid) and France (Carl Zeiss Meditec S.A.S., La Rochelle, and Carl Zeiss Meditec France SAS, Le Pecq).
Carl Zeiss Meditec
Patients Help Crack Nurses' And Midwives' Code, UK
To mark World Health Day, the Nursing & Midwifery Council (NMC) today launches a new Code for the UK's 674,000 nurses and midwives
With events held in Edinburgh, Belfast, Glamorgan and London, the launch of the new Code aims to clarify expectations; setting out for nurses and midwives what is expected of them as professionals, and showing members of the public what standard of care they can expect to receive.
"Practise is continually changing and nurses and midwives are increasingly faced with situations that challenge their accountability," said Nancy Kirkland, NMC President. "Nurses and midwives should see the Code as a support tool to help them in practise so if they are faced with an ethical, moral or professional dilemma, they can refer to the Code for guidance and advice," she said.
As part of the review in 2007, the NMC met with stakeholders from all corners of the UK, including nurses, midwives, employers, members of the public, patient groups, unions and professional bodies. These views have been the primary influence in developing the new Code.
Dee Stanley-Smith, Provider Services Clinical Lead at Derby City PCT who was involved in the consultation process said, "The Code puts into words what it means to be a nurse, spelling out my responsibility to the patient, the service and the profession. It reminds me that I am proud to be a nurse successfully working in an ever-changing world."
A recent NMC online poll of more than 800 nurses and midwives showed that 34 per cent were not confident they knew what was in their Code.
Ms Kirkland added, "Not only are healthcare services continually changing, so too are the needs of patients. Instead of the Code setting out pages of rules, which would be unsuitable considering the varied roles and individual patient needs, the pocket-sized Code provides a broad set of principles that nurses and midwives can apply to their own area of practise and the diverse environments in which patients receive care."
The NMC Code comes into effect on 1 May 2008.
The Nursing & Midwifery Council (NMC) is the UK regulator for two professions, nursing and midwifery. To be eligible to work as a nurse or midwife in the UK, they must be registered with the NMC. There are currently more than 674,000 nurses and midwives on the register. The primary purpose of the NMC is to safeguard the health and wellbeing of the public. It does this through maintaining a register of all nurses and midwives to practise within the UK and by setting standards for their education, training and conduct.
Nursing & Midwifery Council
With events held in Edinburgh, Belfast, Glamorgan and London, the launch of the new Code aims to clarify expectations; setting out for nurses and midwives what is expected of them as professionals, and showing members of the public what standard of care they can expect to receive.
"Practise is continually changing and nurses and midwives are increasingly faced with situations that challenge their accountability," said Nancy Kirkland, NMC President. "Nurses and midwives should see the Code as a support tool to help them in practise so if they are faced with an ethical, moral or professional dilemma, they can refer to the Code for guidance and advice," she said.
As part of the review in 2007, the NMC met with stakeholders from all corners of the UK, including nurses, midwives, employers, members of the public, patient groups, unions and professional bodies. These views have been the primary influence in developing the new Code.
Dee Stanley-Smith, Provider Services Clinical Lead at Derby City PCT who was involved in the consultation process said, "The Code puts into words what it means to be a nurse, spelling out my responsibility to the patient, the service and the profession. It reminds me that I am proud to be a nurse successfully working in an ever-changing world."
A recent NMC online poll of more than 800 nurses and midwives showed that 34 per cent were not confident they knew what was in their Code.
Ms Kirkland added, "Not only are healthcare services continually changing, so too are the needs of patients. Instead of the Code setting out pages of rules, which would be unsuitable considering the varied roles and individual patient needs, the pocket-sized Code provides a broad set of principles that nurses and midwives can apply to their own area of practise and the diverse environments in which patients receive care."
The NMC Code comes into effect on 1 May 2008.
The Nursing & Midwifery Council (NMC) is the UK regulator for two professions, nursing and midwifery. To be eligible to work as a nurse or midwife in the UK, they must be registered with the NMC. There are currently more than 674,000 nurses and midwives on the register. The primary purpose of the NMC is to safeguard the health and wellbeing of the public. It does this through maintaining a register of all nurses and midwives to practise within the UK and by setting standards for their education, training and conduct.
Nursing & Midwifery Council
Replacement Drug For Treating Cocaine Addiction Has Positive Finding In Animal Model
New research in monkeys suggests the feasibility of treating cocaine addiction with a "replacement" drug that mimics the effects of cocaine but has less potential for abuse - similar to the way nicotine and heroin addictions are treated.
Reporting at the annual meeting of the American Society of Pharmacology and Experimental Therapeutics in San Diego, Calif., scientists from Wake Forest University School of Medicine said treating monkeys with amphetamine significantly reduced their self-administration of cocaine for up to a month.
"This suggests the possibility of developing an amphetamine-like drug for treating cocaine addiction," said Paul Czoty, Ph.D., lead author and assistant professor of physiology and pharmacology. "The research also demonstrates the usefulness for conducting studies in monkeys to test potential treatments."
Czoty said the quest to develop a treatment for cocaine addiction has been ongoing for decades with little success. "While we have medications for heroin and tobacco abuse, there is no FDA-approved treatment for cocaine," he said.
With both heroin and tobacco, there are treatments to replace the addictive drug with a drug that has similar effects on the body, but with less potential for abuse.
"With this strategy in mind, clinical researchers have turned to drugs currently available, including amphetamines," said Czoty. "While it's unlikely that amphetamine itself will turn out to be the best treatment, these drugs allow us to prove the concept of using a replacement drug to combat cocaine addiction."
Amphetamines have been used in clinical studies with some success, said Czoty. His research in monkeys may help identify the best dose and schedule for administering a replacement drug - as well as evaluate potential treatment candidates and estimate potential side effects.
For the study, a monkey was taught to press levers multiple times to obtain food or a cocaine injection. With each injection, the number of required lever presses increased so that the animal had to work harder for the cocaine.
"This procedure measures the strength of the reinforcing effects of drugs," said Czoty. "Each injection requires more and more work and eventually it gets to the point where it's not worth it to the monkey because more than 1,000 presses are required."
Access to cocaine was then removed and the monkey was treated intravenously with an amphetamine 24 hours per day. When re-exposed to cocaine one week later, a dramatic decrease in responding for cocaine was observed. They tested three different doses of amphetamine and found that a moderate dose was most effective. Although the treatment also decreased lever-pressing for food - which could be predictive of side effects in humans - this effect disappeared within one week while the effect on responding for cocaine injections persisted for up to one month.
"This was a very positive finding - exactly what we had hoped to see," said Czoty. "Cocaine use was significantly reduced - by about 60 percent."
The researchers are currently repeating the study in additional animals. They hope it could eventually lead to identifying a slightly different drug that will obtain the same results as amphetamines.
Czoty said the study is significant because it and other similar studies in monkeys duplicate what has been found in small studies in humans, which suggests that the animal model can be used to test other treatments. The researchers, for example, plan to test topiramate (Topamax®), an anti-convulsant drug that is sometimes used to treat epilepsy and may be effective in treating alcoholism.
"We have found a model we can use to test new drugs and have an idea of what positive or negative effects would look like," said Czoty.
Reporting at the annual meeting of the American Society of Pharmacology and Experimental Therapeutics in San Diego, Calif., scientists from Wake Forest University School of Medicine said treating monkeys with amphetamine significantly reduced their self-administration of cocaine for up to a month.
"This suggests the possibility of developing an amphetamine-like drug for treating cocaine addiction," said Paul Czoty, Ph.D., lead author and assistant professor of physiology and pharmacology. "The research also demonstrates the usefulness for conducting studies in monkeys to test potential treatments."
Czoty said the quest to develop a treatment for cocaine addiction has been ongoing for decades with little success. "While we have medications for heroin and tobacco abuse, there is no FDA-approved treatment for cocaine," he said.
With both heroin and tobacco, there are treatments to replace the addictive drug with a drug that has similar effects on the body, but with less potential for abuse.
"With this strategy in mind, clinical researchers have turned to drugs currently available, including amphetamines," said Czoty. "While it's unlikely that amphetamine itself will turn out to be the best treatment, these drugs allow us to prove the concept of using a replacement drug to combat cocaine addiction."
Amphetamines have been used in clinical studies with some success, said Czoty. His research in monkeys may help identify the best dose and schedule for administering a replacement drug - as well as evaluate potential treatment candidates and estimate potential side effects.
For the study, a monkey was taught to press levers multiple times to obtain food or a cocaine injection. With each injection, the number of required lever presses increased so that the animal had to work harder for the cocaine.
"This procedure measures the strength of the reinforcing effects of drugs," said Czoty. "Each injection requires more and more work and eventually it gets to the point where it's not worth it to the monkey because more than 1,000 presses are required."
Access to cocaine was then removed and the monkey was treated intravenously with an amphetamine 24 hours per day. When re-exposed to cocaine one week later, a dramatic decrease in responding for cocaine was observed. They tested three different doses of amphetamine and found that a moderate dose was most effective. Although the treatment also decreased lever-pressing for food - which could be predictive of side effects in humans - this effect disappeared within one week while the effect on responding for cocaine injections persisted for up to one month.
"This was a very positive finding - exactly what we had hoped to see," said Czoty. "Cocaine use was significantly reduced - by about 60 percent."
The researchers are currently repeating the study in additional animals. They hope it could eventually lead to identifying a slightly different drug that will obtain the same results as amphetamines.
Czoty said the study is significant because it and other similar studies in monkeys duplicate what has been found in small studies in humans, which suggests that the animal model can be used to test other treatments. The researchers, for example, plan to test topiramate (Topamax®), an anti-convulsant drug that is sometimes used to treat epilepsy and may be effective in treating alcoholism.
"We have found a model we can use to test new drugs and have an idea of what positive or negative effects would look like," said Czoty.
Rapid Weight Gain Of Freshmen Unsubstantiated By Study
The "freshman 15" - the rapid weight gain believed to afflict many new college students when they begin school - appears to be a bit of an urban legend: a cautionary tale often told but not well substantiated.
Now a study of 36 freshmen at Auburn University - located in one of the states with the highest prevalence of obesity in the nation - reports an average gain of only 1.9 pounds during the first semester, with women gaining slightly more than men, and an average gain of only 4.8 pounds for the entire freshman year (with males gaining an average of 5.4 pounds and women gaining an average of 3.2 pounds). Some students lost weight. But even when only those who gained were considered, the average weight gain was 5.8 pounds, a long way from the often-popularized 15.
Dr. Sareen Gropper presented the study at the Experimental Biology 2008 meeting in San Diego on Sunday, April 6. The presentation is part of the scientific program of the American Society for Nutrition.
The 36 freshman (26 females and 10 males) were weighed and their body composition and shape measured when they began college and then again at the end of the fall semester and the end of the spring semester. The urban legend is correct in the sense that a majority of freshmen in the study (71.4 percent) did gain weight, notes Dr. Gropper, but only 21 percent gained five pounds or more. The largest gainers in the fall semester were a woman who gained nine pounds and a male who gained 10 pounds. For the academic year, the largest weight gains observed were 13 pounds for one male and 12 pounds for one female. No one gained the freshman 15.
Dr. Gropper and colleagues have begun a larger study of 240 students who entered Auburn in the fall semester of 2007. Like the pilot study, participants had to be between 17 and 19 years of age, not married, having no children, and without diagnosed eating disorders. At the end of the first semester, 68.7 percent of students had gained weight: an average of 2.1 pounds. Only 21 percent of students gained 5 pounds or more.
Among those who gained weight, the average was 4.1 pounds. Males gained an average of 4.8 pounds and females an average of 3.7 pounds their first semester at college. Seven students (3.3 percent) gained 10 pounds or more, but only one student gained at least 15 pound, a female who gained 16.2 pounds.
"It does happen," says Dr. Gropper, "even if not very often." She and her colleagues are following the 240 students throughout their freshman and beginning of their sophomore years, with questionnaires that examine factors that might contribute to the gain, however small, that the majority of college freshman appear to experience. The researchers also are collecting data on weight changes throughout the year, including five, 10, even 15+ pound losses within the first year of school.
Unique to this study, says Dr. Gropper, is the partnership with colleagues from Auburn University's Department of Consumer Affairs who use a 3-D whole body scanner to collect information on body size and shape. This technology quickly captures exact body measurements, which can be visually displayed in cross sections of body areas like the bust, waist and hips to show where changes occur in measurements over time. Understanding where weight is deposited on the body helps assess the potential risk of diseases such as heart disease and metabolic syndrome.
Now a study of 36 freshmen at Auburn University - located in one of the states with the highest prevalence of obesity in the nation - reports an average gain of only 1.9 pounds during the first semester, with women gaining slightly more than men, and an average gain of only 4.8 pounds for the entire freshman year (with males gaining an average of 5.4 pounds and women gaining an average of 3.2 pounds). Some students lost weight. But even when only those who gained were considered, the average weight gain was 5.8 pounds, a long way from the often-popularized 15.
Dr. Sareen Gropper presented the study at the Experimental Biology 2008 meeting in San Diego on Sunday, April 6. The presentation is part of the scientific program of the American Society for Nutrition.
The 36 freshman (26 females and 10 males) were weighed and their body composition and shape measured when they began college and then again at the end of the fall semester and the end of the spring semester. The urban legend is correct in the sense that a majority of freshmen in the study (71.4 percent) did gain weight, notes Dr. Gropper, but only 21 percent gained five pounds or more. The largest gainers in the fall semester were a woman who gained nine pounds and a male who gained 10 pounds. For the academic year, the largest weight gains observed were 13 pounds for one male and 12 pounds for one female. No one gained the freshman 15.
Dr. Gropper and colleagues have begun a larger study of 240 students who entered Auburn in the fall semester of 2007. Like the pilot study, participants had to be between 17 and 19 years of age, not married, having no children, and without diagnosed eating disorders. At the end of the first semester, 68.7 percent of students had gained weight: an average of 2.1 pounds. Only 21 percent of students gained 5 pounds or more.
Among those who gained weight, the average was 4.1 pounds. Males gained an average of 4.8 pounds and females an average of 3.7 pounds their first semester at college. Seven students (3.3 percent) gained 10 pounds or more, but only one student gained at least 15 pound, a female who gained 16.2 pounds.
"It does happen," says Dr. Gropper, "even if not very often." She and her colleagues are following the 240 students throughout their freshman and beginning of their sophomore years, with questionnaires that examine factors that might contribute to the gain, however small, that the majority of college freshman appear to experience. The researchers also are collecting data on weight changes throughout the year, including five, 10, even 15+ pound losses within the first year of school.
Unique to this study, says Dr. Gropper, is the partnership with colleagues from Auburn University's Department of Consumer Affairs who use a 3-D whole body scanner to collect information on body size and shape. This technology quickly captures exact body measurements, which can be visually displayed in cross sections of body areas like the bust, waist and hips to show where changes occur in measurements over time. Understanding where weight is deposited on the body helps assess the potential risk of diseases such as heart disease and metabolic syndrome.
Sunday, April 6, 2008
Researchers Report Neublastin Virtually Restores Complete Long Term Sensory Motor Function In Preclinical Studies
Biogen Idec (Nasdaq: BIIB), in collaboration with scientists at the University of Arizona and Tufts University reported in the April issue of the journal Nature Neuroscience that in preclinical studies, injections of the protein neublastin promoted the regeneration of damaged sensory nerve cells and produced virtually complete, long-term restoration of sensory and motor function. These studies suggest neublastin has potential for further development as a treatment for traumatic nerve injury.
Neublastin, also known as artemin, belongs to a family of proteins, called glial-derived neurotrophic factors (GDNF), which promote nerve cell survival. The protein is unique because it acts selectively on sensory neurons. In previous preclinical studies, neublastin reversed a number of features of chronic pain associated with peripheral nerve injury.
Specifically in the studies, six neublastin injections were administered over 11 days following injury to the dorsal root, a bundle of peripheral nerve fibers adjacent to the spinal cord that transmit sensory information to the central nervous system. The injections promoted nerve growth into the spinal cord and restored the ability to respond normally to a variety of sensory stimuli and perform complex motor activities such as grasping an object on contact. The functional recovery occurred even after a two-day delay in administering neublastin and lasted for more than six months.
"Sensory nerves entering the spinal cord have minimal capacity to regenerate and severe injury often results in permanent loss of sensory functions," said Frank Porreca, PhD, Professor of Pharmacology at the University of Arizona, the study's senior author. "The results of our preclinical studies, showing dramatic, long-term recovery of pain sensation and complex motor skills after neublastin injections, represent an important and novel advance in research efforts in the area of traumatic nerve injury."
In a series of biochemical, molecular and electrophysiology studies, the researchers also demonstrated that neublastin promoted the regeneration of multiple classes of nerve cells back into the spinal cord and the re-establishment of functional connections with their spinal targets.
"These exciting results support further research, as the data suggest that neublastin may have the potential to promote sensory neuronal regeneration and functional recovery following injury," said Ken Rhodes, PhD, Vice President, Discovery Neurobiology, Biogen Idec. "The neublastin program is part of Biogen Idec's commitment to innovative neurological science and discovery."
Biogen Idec is developing neublastin for use in treating peripheral nervous system diseases under an exclusive license from NsGene. Scientists at NsGene discovered neublastin in 1998.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.
Biogen Idec Safe Harbor
This press release contains forward-looking statements regarding the development of neublastin (also known as artemin) and its potential as a treatment for various indications. These statements are based on Biogen Idec's current beliefs and expectation, based on preclinical studies conducted to date. Drug development involves a high degree of risk. Factors which could cause actual results to differ materially from current expectations include: the risk that unexpected concerns may arise from additional data or analysis, that regulatory authorities may require additional information and/or further studies before further development is conducted, or may fail to approve the drug. The company may also encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec's drug development and other activities, see the periodic reports of Biogen Idec filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Neublastin, also known as artemin, belongs to a family of proteins, called glial-derived neurotrophic factors (GDNF), which promote nerve cell survival. The protein is unique because it acts selectively on sensory neurons. In previous preclinical studies, neublastin reversed a number of features of chronic pain associated with peripheral nerve injury.
Specifically in the studies, six neublastin injections were administered over 11 days following injury to the dorsal root, a bundle of peripheral nerve fibers adjacent to the spinal cord that transmit sensory information to the central nervous system. The injections promoted nerve growth into the spinal cord and restored the ability to respond normally to a variety of sensory stimuli and perform complex motor activities such as grasping an object on contact. The functional recovery occurred even after a two-day delay in administering neublastin and lasted for more than six months.
"Sensory nerves entering the spinal cord have minimal capacity to regenerate and severe injury often results in permanent loss of sensory functions," said Frank Porreca, PhD, Professor of Pharmacology at the University of Arizona, the study's senior author. "The results of our preclinical studies, showing dramatic, long-term recovery of pain sensation and complex motor skills after neublastin injections, represent an important and novel advance in research efforts in the area of traumatic nerve injury."
In a series of biochemical, molecular and electrophysiology studies, the researchers also demonstrated that neublastin promoted the regeneration of multiple classes of nerve cells back into the spinal cord and the re-establishment of functional connections with their spinal targets.
"These exciting results support further research, as the data suggest that neublastin may have the potential to promote sensory neuronal regeneration and functional recovery following injury," said Ken Rhodes, PhD, Vice President, Discovery Neurobiology, Biogen Idec. "The neublastin program is part of Biogen Idec's commitment to innovative neurological science and discovery."
Biogen Idec is developing neublastin for use in treating peripheral nervous system diseases under an exclusive license from NsGene. Scientists at NsGene discovered neublastin in 1998.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.
Biogen Idec Safe Harbor
This press release contains forward-looking statements regarding the development of neublastin (also known as artemin) and its potential as a treatment for various indications. These statements are based on Biogen Idec's current beliefs and expectation, based on preclinical studies conducted to date. Drug development involves a high degree of risk. Factors which could cause actual results to differ materially from current expectations include: the risk that unexpected concerns may arise from additional data or analysis, that regulatory authorities may require additional information and/or further studies before further development is conducted, or may fail to approve the drug. The company may also encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec's drug development and other activities, see the periodic reports of Biogen Idec filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Data From Ortho Biotech Sponsored Studies To Be Presented At National Kidney Foundation 2008 Spring Clinical Meetings
Data from five studies sponsored by Ortho Biotech Products, L.P. will be presented at the National Kidney Foundation (NKF) 2008 Spring Clinical Meetings from April 2 - 6, 2008; three utilization studies involve PROCRIT® (Epoetin alfa).
The data include studies that compare drug utilization patterns and costs of PROCRIT® (EPO) and darbepoetin alfa (DARB), evaluate medical costs related to chronic kidney disease (CKD) patients with hypertension or diabetes, and show the impact on hemoglobin (Hb) control using a software-based management tool. These retrospective analyses used data from actual clinical practice.
Data on Drug Utilization Patterns and Costs of Epoetin Alfa and Darbepoetin Alfa
Abstract: Assessment of Drug Utilization Patterns and Costs for Erythropoietic Stimulating Agents in Patients with Chronic Kidney Disease
Patrick Lefebvre, M.A., Groupe d'analyse, Ltée, Montréal, Québec, Canada
A retrospective analysis of medical claims was conducted using the Ingenix Impact National Managed Care Database to examine recent EPO and DARB treatment patterns and corresponding drug costs in newly-initiated CKD patients treated with EPO (n=1,110) or DARB (n=723) not receiving dialysis.bMean cumulative dose was used to calculate drug costs based on October 2007 wholesale acquisition unit prices.
Abstract: Drug Utilization and Cost Considerations of Predialysis Chronic Kidney Disease Patients Receiving Erythropoietic Stimulating Agents Through Pharmacy Benefits
François Laliberté, M.A., Groupe d'analyse, Ltée, Montréal, Québec, Canada
A retrospective analysis of pharmacy claims using the PharMetrics Patient-Centric Database, which represents approximately 85 managed healthcare plans, was conducted to compare drug utilization patterns and costs of a newly-initiated, managed care predialysis chronic kidney disease population receiving EPO (n=1,066) or DARB (n=375) through a pharmacy benefit. Drug cost was based on cumulative dose and October 2007 wholesale acquisition cost.
Data on Medical Costs Related to Chronic Kidney Disease Patients with Hypertension or Diabetes
Abstract: Medical Costs of Chronic Kidney Disease in Patients with Diabetes: A Managed Care Perspective
François Laliberté, M.A., Groupe d'analyse, Ltée, Montréal, Québec, Canada
A retrospective analysis of medical claims and laboratory data from a large managed care database was conducted to quantify the incremental direct healthcare costs of CKD in patients with diabetes. Analyses compared diabetes patients who developed CKD versus those who did not for yearly direct healthcare costs, which consisted of outpatient services, inpatient services and pharmacy dispensing claims. A total of 30,480 patients with diabetes were identified, of whom 859 developed CKD during the study period.
Abstract: The Effect of Anemia in Hypertensive Patients with Chronic Kidney Disease: Hospital Costs and Length of Stay
Sandra Sulsky, M.P.H, Ph.D., ENVIRON International Corporation, Amherst, MA
A retrospective analysis of hospital discharge records from the 2004 Nationwide Inpatient Sample of the Hospital Cost and Utilization Project, which comprises approximately 90 percent of all hospital discharges in the U.S., was conducted to determine the effect of anemia on hospital costs and length of stay in hypertensive patients with CKD. Analyses were adjusted for age, gender, income level, severity of disease, and hospital characteristics to control for the confounding effects of anemia, CKD and a combination of both on study outcomes.
Data on the Impact on Hemoglobin Control Using a Software-Based Management Tool
Abstract: Use of Epoetin Alfa in Maintaining Hemoglobin Control Through a Software-Based Management Tool in a Community Nephrology Setting
Craig Kleinmann, D.O., Nephrology Associates, Mobile, AL
A retrospective, observational chart review from a large U.S. nephrology clinic was conducted in May 2007 to analyze the impact of EPO on mean Hb over time as well as subsequent dose holds in anemic non-dialysis CKD patients in a community practice setting using TrakAnemia, a software-based tool. Eighty-seven patients who had a documented diagnosis of anemia due to non-dialysis CKD, initiated EPO, and had greater than or equal to six months of follow-up data were included in the final analysis.
About PROCRIT® (Epoetin alfa)
PROCRIT® is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.
Important U.S. Safety Information for PROCRIT®
Boxed WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION
Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
Cancer:
-- ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of > 12 g/dL.
-- The risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.
-- To minimize these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusions.
-- Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
-- Discontinue following the completion of a chemotherapy course.
Perisurgery: PROCRIT® increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
Contraindications
PROCRIT® is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.
Additional Important Safety Information
The dose of PROCRIT should be titrated for each patient to achieve and maintain the following hemoglobin levels:
Chronic renal failure patients hemoglobin levels between 10 to 12 g/dL. If a patient does not attain hemoglobin levels of 10 to 12 g/dL despite 12 weeks of appropriate PROCRIT® therapy, see DOSAGE and ADMINISTRATION in the PROCRIT® Prescribing Information.
Cancer or HIV patients the lowest hemoglobin level sufficient to avoid transfusion and not to exceed 12 g/dL.
Monitor hemoglobin regularly during therapy, more frequently following a dosage adjustment or until hemoglobin becomes stable.
Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients with chronic renal failure receiving PROCRIT® by subcutaneous administration. If any patient develops a sudden loss of response to PROCRIT® , accompanied by severe anemia and low reticulocyte count, and anti-erythropoietin antibody-associated anemia is suspected, withhold PROCRIT® and other erythropoietic proteins. Contact ORTHO BIOTECH (1-888-2ASKOBI or 1-888-227-5624) to perform assays for binding and neutralizing antibodies. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT® should be permanently discontinued and patients should not be switched to other erythropoietic proteins.
-- The safety and efficacy of PROCRIT® therapy have not been established in patients with a known history of a seizure disorder or underlying hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes or hypercoagulable disorders).
-- In some female patients, menses have resumed following PROCRIT® therapy; the possibility of pregnancy should be discussed and the need for contraception evaluated.
-- Prior to and regularly during PROCRIT® therapy monitor iron status; transferrin saturation should be ³ 20% and ferritin should be ³ 100 ng/mL. During therapy absolute or functional iron deficiency may develop and all patients will eventually require supplemental iron to adequately support erythropoiesis stimulated by PROCRIT®.
-- During PROCRIT® therapy, blood pressure should be monitored carefully and aggressively managed, particularly in patients with an underlying history of hypertension or cardiovascular disease.
-- In studies, the most common side effects included fever (pyrexia), diarrhea, nausea, vomiting, swelling of hands or feet (edema), lack or loss of strength or weakness (asthenia, fatigue), shortness of breath, high blood pressure, headache, joint pain (arthralgias), abnormal skin sensations (as tingling or tickling or itching or burning; paresthesia), rash, constipation and upper respiratory infection.
Please visit http://www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.
About Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit http://www.orthobiotech.com
The data include studies that compare drug utilization patterns and costs of PROCRIT® (EPO) and darbepoetin alfa (DARB), evaluate medical costs related to chronic kidney disease (CKD) patients with hypertension or diabetes, and show the impact on hemoglobin (Hb) control using a software-based management tool. These retrospective analyses used data from actual clinical practice.
Data on Drug Utilization Patterns and Costs of Epoetin Alfa and Darbepoetin Alfa
Abstract: Assessment of Drug Utilization Patterns and Costs for Erythropoietic Stimulating Agents in Patients with Chronic Kidney Disease
Patrick Lefebvre, M.A., Groupe d'analyse, Ltée, Montréal, Québec, Canada
A retrospective analysis of medical claims was conducted using the Ingenix Impact National Managed Care Database to examine recent EPO and DARB treatment patterns and corresponding drug costs in newly-initiated CKD patients treated with EPO (n=1,110) or DARB (n=723) not receiving dialysis.bMean cumulative dose was used to calculate drug costs based on October 2007 wholesale acquisition unit prices.
Abstract: Drug Utilization and Cost Considerations of Predialysis Chronic Kidney Disease Patients Receiving Erythropoietic Stimulating Agents Through Pharmacy Benefits
François Laliberté, M.A., Groupe d'analyse, Ltée, Montréal, Québec, Canada
A retrospective analysis of pharmacy claims using the PharMetrics Patient-Centric Database, which represents approximately 85 managed healthcare plans, was conducted to compare drug utilization patterns and costs of a newly-initiated, managed care predialysis chronic kidney disease population receiving EPO (n=1,066) or DARB (n=375) through a pharmacy benefit. Drug cost was based on cumulative dose and October 2007 wholesale acquisition cost.
Data on Medical Costs Related to Chronic Kidney Disease Patients with Hypertension or Diabetes
Abstract: Medical Costs of Chronic Kidney Disease in Patients with Diabetes: A Managed Care Perspective
François Laliberté, M.A., Groupe d'analyse, Ltée, Montréal, Québec, Canada
A retrospective analysis of medical claims and laboratory data from a large managed care database was conducted to quantify the incremental direct healthcare costs of CKD in patients with diabetes. Analyses compared diabetes patients who developed CKD versus those who did not for yearly direct healthcare costs, which consisted of outpatient services, inpatient services and pharmacy dispensing claims. A total of 30,480 patients with diabetes were identified, of whom 859 developed CKD during the study period.
Abstract: The Effect of Anemia in Hypertensive Patients with Chronic Kidney Disease: Hospital Costs and Length of Stay
Sandra Sulsky, M.P.H, Ph.D., ENVIRON International Corporation, Amherst, MA
A retrospective analysis of hospital discharge records from the 2004 Nationwide Inpatient Sample of the Hospital Cost and Utilization Project, which comprises approximately 90 percent of all hospital discharges in the U.S., was conducted to determine the effect of anemia on hospital costs and length of stay in hypertensive patients with CKD. Analyses were adjusted for age, gender, income level, severity of disease, and hospital characteristics to control for the confounding effects of anemia, CKD and a combination of both on study outcomes.
Data on the Impact on Hemoglobin Control Using a Software-Based Management Tool
Abstract: Use of Epoetin Alfa in Maintaining Hemoglobin Control Through a Software-Based Management Tool in a Community Nephrology Setting
Craig Kleinmann, D.O., Nephrology Associates, Mobile, AL
A retrospective, observational chart review from a large U.S. nephrology clinic was conducted in May 2007 to analyze the impact of EPO on mean Hb over time as well as subsequent dose holds in anemic non-dialysis CKD patients in a community practice setting using TrakAnemia, a software-based tool. Eighty-seven patients who had a documented diagnosis of anemia due to non-dialysis CKD, initiated EPO, and had greater than or equal to six months of follow-up data were included in the final analysis.
About PROCRIT® (Epoetin alfa)
PROCRIT® is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.
Important U.S. Safety Information for PROCRIT®
Boxed WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION
Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
Cancer:
-- ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of > 12 g/dL.
-- The risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.
-- To minimize these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusions.
-- Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
-- Discontinue following the completion of a chemotherapy course.
Perisurgery: PROCRIT® increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
Contraindications
PROCRIT® is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.
Additional Important Safety Information
The dose of PROCRIT should be titrated for each patient to achieve and maintain the following hemoglobin levels:
Chronic renal failure patients hemoglobin levels between 10 to 12 g/dL. If a patient does not attain hemoglobin levels of 10 to 12 g/dL despite 12 weeks of appropriate PROCRIT® therapy, see DOSAGE and ADMINISTRATION in the PROCRIT® Prescribing Information.
Cancer or HIV patients the lowest hemoglobin level sufficient to avoid transfusion and not to exceed 12 g/dL.
Monitor hemoglobin regularly during therapy, more frequently following a dosage adjustment or until hemoglobin becomes stable.
Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients with chronic renal failure receiving PROCRIT® by subcutaneous administration. If any patient develops a sudden loss of response to PROCRIT® , accompanied by severe anemia and low reticulocyte count, and anti-erythropoietin antibody-associated anemia is suspected, withhold PROCRIT® and other erythropoietic proteins. Contact ORTHO BIOTECH (1-888-2ASKOBI or 1-888-227-5624) to perform assays for binding and neutralizing antibodies. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT® should be permanently discontinued and patients should not be switched to other erythropoietic proteins.
-- The safety and efficacy of PROCRIT® therapy have not been established in patients with a known history of a seizure disorder or underlying hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes or hypercoagulable disorders).
-- In some female patients, menses have resumed following PROCRIT® therapy; the possibility of pregnancy should be discussed and the need for contraception evaluated.
-- Prior to and regularly during PROCRIT® therapy monitor iron status; transferrin saturation should be ³ 20% and ferritin should be ³ 100 ng/mL. During therapy absolute or functional iron deficiency may develop and all patients will eventually require supplemental iron to adequately support erythropoiesis stimulated by PROCRIT®.
-- During PROCRIT® therapy, blood pressure should be monitored carefully and aggressively managed, particularly in patients with an underlying history of hypertension or cardiovascular disease.
-- In studies, the most common side effects included fever (pyrexia), diarrhea, nausea, vomiting, swelling of hands or feet (edema), lack or loss of strength or weakness (asthenia, fatigue), shortness of breath, high blood pressure, headache, joint pain (arthralgias), abnormal skin sensations (as tingling or tickling or itching or burning; paresthesia), rash, constipation and upper respiratory infection.
Please visit http://www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.
About Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit http://www.orthobiotech.com
Cancer Research Taking The Main Stage At Baylor University
Two Baylor University faculty members are working to create and test dozens of new cancer fighting compounds that disrupt solid cancer tumors and target any remaining tumor cells that may grow after the tumor is treated. In another project, two Baylor adjunct faculty members and a Baylor graduate student are developing vaccines against melanoma. These are just two examples of some of the latest cancer research projects faculty and students are involved with at Baylor and at Baylor's Institute of Biomedical Studies.
With more than 30 students and more than 40 faculty and adjunct faculty members, Baylor's Institute of Biomedical Studies is an interdisciplinary program in biomedical-related areas of science leading to the doctoral degree. The program combines graduate students with an extremely diverse faculty who are actively involved in basic and translational research, both at Baylor University in Waco and at the Baylor University Medical Center (BUMC) in Dallas.
Cancer research funding comes from numerous public and private outlets, including one project that is looking into two main kinds of tumor-starving compounds, which has resulted in several patents for several Baylor professors like Dr. Kevin Pinney, professor of chemistry at Baylor. In Pinney's research, he and his team are creating new bioreductive compounds that take advantage of the lack of oxygen in the tumor. These compounds damage the tumor's DNA, so the tumor can not divide effectively. In another project, Baylor researchers are working to create a new type of Vascular Disrupting Agent. VDAs target the flow of blood to solid cancer tumors and other abnormal blood vessels while leaving healthy cells intact.
Baylor University
One Bear Pl. #97024
Waco, TX 76798-7024
United States
http://www.baylor.edu
With more than 30 students and more than 40 faculty and adjunct faculty members, Baylor's Institute of Biomedical Studies is an interdisciplinary program in biomedical-related areas of science leading to the doctoral degree. The program combines graduate students with an extremely diverse faculty who are actively involved in basic and translational research, both at Baylor University in Waco and at the Baylor University Medical Center (BUMC) in Dallas.
Cancer research funding comes from numerous public and private outlets, including one project that is looking into two main kinds of tumor-starving compounds, which has resulted in several patents for several Baylor professors like Dr. Kevin Pinney, professor of chemistry at Baylor. In Pinney's research, he and his team are creating new bioreductive compounds that take advantage of the lack of oxygen in the tumor. These compounds damage the tumor's DNA, so the tumor can not divide effectively. In another project, Baylor researchers are working to create a new type of Vascular Disrupting Agent. VDAs target the flow of blood to solid cancer tumors and other abnormal blood vessels while leaving healthy cells intact.
Baylor University
One Bear Pl. #97024
Waco, TX 76798-7024
United States
http://www.baylor.edu
Scarless Nephrectomy By Transgastric And Transvesical Combined Approach
UroToday.com - Dr. Lima from Porto, Portugal presented the novel concept of "natural orifices translumenal endoscopic surgery" (NOTES) as applied to nephrectomy in an experimental model. Their team assessed the feasibility of a combined transgastric and transvesical approach for performing nephrectomy in a porcine model.
In a non-survival study, a transgastric and transvesical combined approach was applied in 6 female pigs. Under ureteroscopic control, they placed a transvesical 5-mm over tube into the peritoneal cavity, and a flexible gastroscope was passed orally into the peritoneal cavity by a gastrotomy. Four right and two left nephrectomies were performed using instruments introduced by both devices. The pigs suffered no complications during creation of transvesical and transgastric access. In all animals, they visualized both kidneys, and the renal vessels and ureter were identified and ligated separately with ultrasonic scissors, which were introduced through the transvesical port. In two early cases, mild bleeding occurred after ultrasonic ligation. Complete renal release and mobilization to the stomach was achieved in all animals. During the discussion, it became apparent that none of the "resected" kidneys were removed from the porcine bodies, and this would require some sort of incision.
Presented by: E. Lima, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
Reported by UroToday.com Contributing Editor, Christopher P. Evans, MD
UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.
To access the latest urology news releases from UroToday, go to: www.urotoday.com
Copyright © 2008 - UroToday
In a non-survival study, a transgastric and transvesical combined approach was applied in 6 female pigs. Under ureteroscopic control, they placed a transvesical 5-mm over tube into the peritoneal cavity, and a flexible gastroscope was passed orally into the peritoneal cavity by a gastrotomy. Four right and two left nephrectomies were performed using instruments introduced by both devices. The pigs suffered no complications during creation of transvesical and transgastric access. In all animals, they visualized both kidneys, and the renal vessels and ureter were identified and ligated separately with ultrasonic scissors, which were introduced through the transvesical port. In two early cases, mild bleeding occurred after ultrasonic ligation. Complete renal release and mobilization to the stomach was achieved in all animals. During the discussion, it became apparent that none of the "resected" kidneys were removed from the porcine bodies, and this would require some sort of incision.
Presented by: E. Lima, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
Reported by UroToday.com Contributing Editor, Christopher P. Evans, MD
UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.
To access the latest urology news releases from UroToday, go to: www.urotoday.com
Copyright © 2008 - UroToday
Management Of Superficial Bladder Tumors
UroToday.com - An Italian study group presented data on the optimal schedule regimen and the role of maintenance intravesical chemotherapy or BCG immunotherapy after transurethral resection (TUR for non muscle-invasive transitional cell cancer of the bladder (NMI TCCB) for patients at intermediate risk.
Between 2002 and 2003, 577 patients, undergoing TUR for NMI TCCB, were recruited. All patients underwent TUR and early (within 6 hours) intravesical chemotherapy with epirubicin at the dose of 80 mg diluted in 60 ml of saline solution. When histology was available, 95 patients were excluded from the study since they were harboring T1G3, TIS and single and primary Ta G1-G2 tumors. 482 patients with intermediate risk tumors were randomized according 2 different regimens: arm A: 5 more weekly instillations; arm B: 5 more weekly instillations plus monthly instillations for a total of 16 instillations. All patients were submitted every 3 months for the first 2 years and then 6-monthly to cytology, cystoscopy and biopsy of every suspicious bladder lesion.
From 482 randomized patients, 396 are evaluable for toxicity and 392 for efficacy. The tumors were multiple in 318 patients (66.2%) and recurrent in 192 (39.8%). No difference emerged between the 2 arms in relation to tumors' characteristics. The median follow-up time was 22 months. Eighty-two (20.9%) patients recurred at a median time of 9 months from TUR and 4 patients (1%) progressed. The incidence of recurrences was 24.4% in arm A and 18.5% in arm B. No difference emerged between the two arms for recurrence rate at 3 months. Statistical analysis demonstrated an advantage in favor of maintenance in terms of recurrence rate at 6 (p=0.01), 9 (p=0.04) and 12 months (p=0.03) and in terms of recurrence-free interval (p=0.03). No difference for toxicity emerged according to treatment schedule. The conclusion is that 0ne-year maintenance significantly reduces the risk of tumor recurrence, without enhanced toxicity, in patients with intermediate risk NMI TCCB treated with early epirubicin intravesical chemotherapy followed by 5 weekly instillations.
Presented by: V. Serretta, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
Reported by UroToday.com Contributing Editor, Christopher P. Evans, MD
UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.
To access the latest urology news releases from UroToday, go to: www.urotoday.com
Copyright © 2008 - UroToday
Between 2002 and 2003, 577 patients, undergoing TUR for NMI TCCB, were recruited. All patients underwent TUR and early (within 6 hours) intravesical chemotherapy with epirubicin at the dose of 80 mg diluted in 60 ml of saline solution. When histology was available, 95 patients were excluded from the study since they were harboring T1G3, TIS and single and primary Ta G1-G2 tumors. 482 patients with intermediate risk tumors were randomized according 2 different regimens: arm A: 5 more weekly instillations; arm B: 5 more weekly instillations plus monthly instillations for a total of 16 instillations. All patients were submitted every 3 months for the first 2 years and then 6-monthly to cytology, cystoscopy and biopsy of every suspicious bladder lesion.
From 482 randomized patients, 396 are evaluable for toxicity and 392 for efficacy. The tumors were multiple in 318 patients (66.2%) and recurrent in 192 (39.8%). No difference emerged between the 2 arms in relation to tumors' characteristics. The median follow-up time was 22 months. Eighty-two (20.9%) patients recurred at a median time of 9 months from TUR and 4 patients (1%) progressed. The incidence of recurrences was 24.4% in arm A and 18.5% in arm B. No difference emerged between the two arms for recurrence rate at 3 months. Statistical analysis demonstrated an advantage in favor of maintenance in terms of recurrence rate at 6 (p=0.01), 9 (p=0.04) and 12 months (p=0.03) and in terms of recurrence-free interval (p=0.03). No difference for toxicity emerged according to treatment schedule. The conclusion is that 0ne-year maintenance significantly reduces the risk of tumor recurrence, without enhanced toxicity, in patients with intermediate risk NMI TCCB treated with early epirubicin intravesical chemotherapy followed by 5 weekly instillations.
Presented by: V. Serretta, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
Reported by UroToday.com Contributing Editor, Christopher P. Evans, MD
UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.
To access the latest urology news releases from UroToday, go to: www.urotoday.com
Copyright © 2008 - UroToday
Management Of Superficial Bladder Tumors
UroToday.com - This presentation addressed the issue that recurrence at first follow-up cystoscopy (RR-FFC) after TURBT has been attributed to incomplete resection of the tumor. Furthermore, an EORTC analysis of multicenter trials suggested the inter-institutional variability of RR-FFC was a result of variable TURBT 'quality'. Dr. Mariappan and members of the Edinburgh Uro-Oncology Group aimed to determine if (a) detrusor muscle can be a surrogate marker of this 'quality' and (b) the presence of detrusor is dependant on surgeon's experience.
The researchers reviewed their prospectively maintained database of patients with newly diagnosed bladder tumors in 2005-2006, to determine surgeon status, tumor characteristics and RR-FFC. Only patients with complete resections as determined by the surgeon were included. For analysis, surgeons were stratified into (a) seniors (consultant and Year 5 or 6 trainees) and (b) juniors (trainees < year 5). One investigator, blinded to the above characteristics, interrogated our pathology database to confirm histological tumor grade, stage and detrusor muscle status. Logistic regression analysis was carried out.
A total of 356 patients were suitable for analysis. The majority of tumors in this cohort were small (73.3%), single (84.6%) and high grade (48.3%). Seniors performed 66.1% of the resections. Overall, detrusor muscle was present in 241 (67.7%) of resections. Logistic regression multivariate analysis revealed large tumors, high grade tumors and surgery carried out by senior surgeons were associated with presence of detrusor (Table 1). The overall RR-FFC was 26.8%. The risk of early recurrence following TURBT was 35.9% and 21.5% when detrusor muscle was absent and present, respectively (OR=2.1, 95%CI=1.1-4, p=0.02). Dr. Mariappan concluded that the presence of detrusor muscle in the TURBT specimen was more likely when surgery was performed by senior surgeons and this predicted a lower RR-FFC. This parameter appears to be a surrogate marker of the quality of TURBT.
Presented by: P. Mariappan, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
Reported by UroToday.com Contributing Editor, Christopher P. Evans, MD
UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.
To access the latest urology news releases from UroToday, go to: www.urotoday.com
Copyright © 2008 - UroToday
The researchers reviewed their prospectively maintained database of patients with newly diagnosed bladder tumors in 2005-2006, to determine surgeon status, tumor characteristics and RR-FFC. Only patients with complete resections as determined by the surgeon were included. For analysis, surgeons were stratified into (a) seniors (consultant and Year 5 or 6 trainees) and (b) juniors (trainees < year 5). One investigator, blinded to the above characteristics, interrogated our pathology database to confirm histological tumor grade, stage and detrusor muscle status. Logistic regression analysis was carried out.
A total of 356 patients were suitable for analysis. The majority of tumors in this cohort were small (73.3%), single (84.6%) and high grade (48.3%). Seniors performed 66.1% of the resections. Overall, detrusor muscle was present in 241 (67.7%) of resections. Logistic regression multivariate analysis revealed large tumors, high grade tumors and surgery carried out by senior surgeons were associated with presence of detrusor (Table 1). The overall RR-FFC was 26.8%. The risk of early recurrence following TURBT was 35.9% and 21.5% when detrusor muscle was absent and present, respectively (OR=2.1, 95%CI=1.1-4, p=0.02). Dr. Mariappan concluded that the presence of detrusor muscle in the TURBT specimen was more likely when surgery was performed by senior surgeons and this predicted a lower RR-FFC. This parameter appears to be a surrogate marker of the quality of TURBT.
Presented by: P. Mariappan, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
Reported by UroToday.com Contributing Editor, Christopher P. Evans, MD
UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.
To access the latest urology news releases from UroToday, go to: www.urotoday.com
Copyright © 2008 - UroToday
Laparoscopic Renal Cryoablation (LRC) Of Small Renal Masses
UroToday.com - A group from Milan, Italy prospectively analyzed the outcome of patients with kidney masses treated with laparoscopic cryoablation over a 7-year period. Beginning in September 2000, 104 patients (mean age 61.6 years; 78 male and 26 female) underwent LRC for renal masses. The mean lesion diameter was 2.2cm. The procedure was performed transperitoneally in 60 cases and in 44 patients it was done retroperitoneoscopically, based upon the tumor position or potential difficulties due to previous abdominal surgery. Fifty-six patients (54%) had concomitant comorbidities.
The intra-operative mean diameter of the ice ball was 4.93cm. All the procedures were successfully completed laparoscopically, except 3 cases that were converted to open surgery, two of them due to bleeding from the site of the cryoprobe insertion (one of them requiring radical nephrectomy). Mean surgical time was 202.6min (range 90-320 min) and mean intra-operative blood loss was 211.6 cc (range 10-3.200 cc). Pathological evaluation of the intra-operative needle biopsies documented renal cell carcinoma in 64 cases, 23 oncocytomas, 6 angiomyolipomas, 1 case of Xantogranulomatous pyelonephritis and 10 cases "undefined" disease. Post-operative stay was 4.7 days (range 2-13). Postoperative complications were always treated conservatively and included 7 cases of transient fever, 2 cases of small peri-renal hematomas, 1 case of pulmonary edema, 9 patients with significant blood loss and 1 case of gross hematuria. Delayed complication included 1 case of UPJ obstruction requiring open pyeloplasty 8 months after surgery and open nephrectomy one year after surgery due to suspected recurrence of the disease. Six patients died during the follow-up, 5 due to previous illness and 1 patient due to worsening cirrhosis one month after surgery. No patients died secondary to renal cancer.
MRI scans on postoperative day one revealed a mean lesion of 4.91cm. Progressive reduction in size of the ablated lesion was visible in all patients with only a renal scar visible after 24 months of follow-up. This remained constant over time with 36 patients being followed up for 5 years and 11 patients for 7. In the question period, Dr. Jewett (Toronto) pointed out that 40% of the patients with benign lesions had unnecessary treatment and perhaps the biopsies should be performed a few weeks prior to the intended procedure.
Presented by: A. Cestari, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
Reported by UroToday.com Contributing Editor, Christopher P. Evans, MD
UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.
To access the latest urology news releases from UroToday, go to: www.urotoday.com
Copyright © 2008 - UroToday
The intra-operative mean diameter of the ice ball was 4.93cm. All the procedures were successfully completed laparoscopically, except 3 cases that were converted to open surgery, two of them due to bleeding from the site of the cryoprobe insertion (one of them requiring radical nephrectomy). Mean surgical time was 202.6min (range 90-320 min) and mean intra-operative blood loss was 211.6 cc (range 10-3.200 cc). Pathological evaluation of the intra-operative needle biopsies documented renal cell carcinoma in 64 cases, 23 oncocytomas, 6 angiomyolipomas, 1 case of Xantogranulomatous pyelonephritis and 10 cases "undefined" disease. Post-operative stay was 4.7 days (range 2-13). Postoperative complications were always treated conservatively and included 7 cases of transient fever, 2 cases of small peri-renal hematomas, 1 case of pulmonary edema, 9 patients with significant blood loss and 1 case of gross hematuria. Delayed complication included 1 case of UPJ obstruction requiring open pyeloplasty 8 months after surgery and open nephrectomy one year after surgery due to suspected recurrence of the disease. Six patients died during the follow-up, 5 due to previous illness and 1 patient due to worsening cirrhosis one month after surgery. No patients died secondary to renal cancer.
MRI scans on postoperative day one revealed a mean lesion of 4.91cm. Progressive reduction in size of the ablated lesion was visible in all patients with only a renal scar visible after 24 months of follow-up. This remained constant over time with 36 patients being followed up for 5 years and 11 patients for 7. In the question period, Dr. Jewett (Toronto) pointed out that 40% of the patients with benign lesions had unnecessary treatment and perhaps the biopsies should be performed a few weeks prior to the intended procedure.
Presented by: A. Cestari, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy
Reported by UroToday.com Contributing Editor, Christopher P. Evans, MD
UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.
To access the latest urology news releases from UroToday, go to: www.urotoday.com
Copyright © 2008 - UroToday
Non Hodgkin Lymphoma Is Focus Of Cancer In Iowa Report
Non-Hodgkin lymphoma is one of the most rapidly increasing types of cancer diagnosed in the United States with new diagnoses having more than doubled since the 1970s. However, over the past 10 years, mortality rates have begun to decline, indicating that progress is being made in its treatment.
According to the newly issued State Health Registry of Iowa "Cancer in Iowa: 2008" report, non-Hodgkin lymphoma will cause an estimated 270 cancer deaths in Iowa in 2008, accounting for 4.3 percent of cancer deaths in both men and women. This year in Iowa, there will be an estimated 740 new cases (340 women and 400 men), making non-Hodgkin lymphoma the sixth most common cancer in Iowa.
"The exact causes of non-Hodgkin lymphoma are not known, and there are no routine or simple screening methods," said Charles Lynch, M.D., Ph.D., medical director of the registry, which is based in the Department of Epidemiology at the University of Iowa College of Public Health. "Certain risk factors have been shown to be associated with the disease, including a weak immune system, some types of viruses and bacteria, environmental risk factors like pesticides, and occupations such as farming."
"Although Iowa is a farming state, its rates of non-Hodgkin lymphoma are close to the national average," added Lynch, who also is a University of Iowa professor of epidemiology. "This indicates that farming is not a major risk factor for this disease."
Non-Hodgkin lymphoma originates in a subset of white blood cells called lymphocytes, which are part of the body's immune system. The disease can occur in people of all ages and swell lymph nodes, create masses and cause weight loss and fatigue.
"Non-Hodgkin lymphoma is a spectrum of diseases that share similarities but also can be separated into subtypes that are increasingly being found to have unique risk factors and to respond to different therapies," Lynch said.
Some subtypes of non-Hodgkin lymphoma are among the most aggressive of all cancers, while other subtypes are so slow growing, they do not even need immediate treatment, noted George Weiner, M.D., director of the Specialized Program for Research Excellence (SPORE) in lymphoma research at the University of Iowa and head of Holden Comprehensive Cancer Center at the UI.
The University of Iowa's lymphoma SPORE, funded by the National Cancer Institute, is one of only three lymphoma SPORE grant programs in the country. Experts at Mayo Clinic work with the UI as part of the UI SPORE grant. More than 2,000 patients participate in the SPORE.
"A primary goal of the SPORE is to understand how lymphoma treatments work and how to improve them," Weiner said "We are making significant progress in the treatment of non-Hodgkin lymphoma due partly to figuring out how to use the immune system to fight this cancer.
Anti-lymphoma monoclonal antibodies are extremely helpful in treating many lymphoma patients, but not in others, Weiner said. One project supported by the SPORE focuses on understanding these differences by exploring in detail how antibodies direct the patient's own immune system to attack the lymphoma. Another is evaluating how inborn differences in the immune system impact on how well the antibodies work.
"This SPORE research is leading to new approaches to using current antibodies and to the design of stronger antibodies that we hope will be better than those currently available. This research could have an impact on other cancers, as well," Weiner said.
More than 150 hospitals, clinics and medical laboratories across Iowa, as well as referral facilities in neighboring states, contribute data to the State Health Registry of Iowa. The registry is one of 17 registries nationwide that currently are funded to provide data to the National Cancer Institute. Iowa's registry staff includes 50 members, half of whom are located throughout the state and help collect data from many facilities. The registry has been gathering cancer incidence and follow-up data for the state since 1973.
To learn more about non-Hodgkin lymphoma, visit the National Cancer Institute at http://www.cancer.gov/cancertopics/types/non-hodgkin.
To learn more about the University of Iowa and Mayo Clinic Specialized Program of Research Excellence in lymphoma based at the University of Iowa, visit http://www.uihealthcare.com/depts/cancercenter/research/ncispore.html.
University of Iowa Health Sciences
5141 Westlawn
Iowa City, IA 52242
United States
http://www.uiowa.edu
According to the newly issued State Health Registry of Iowa "Cancer in Iowa: 2008" report, non-Hodgkin lymphoma will cause an estimated 270 cancer deaths in Iowa in 2008, accounting for 4.3 percent of cancer deaths in both men and women. This year in Iowa, there will be an estimated 740 new cases (340 women and 400 men), making non-Hodgkin lymphoma the sixth most common cancer in Iowa.
"The exact causes of non-Hodgkin lymphoma are not known, and there are no routine or simple screening methods," said Charles Lynch, M.D., Ph.D., medical director of the registry, which is based in the Department of Epidemiology at the University of Iowa College of Public Health. "Certain risk factors have been shown to be associated with the disease, including a weak immune system, some types of viruses and bacteria, environmental risk factors like pesticides, and occupations such as farming."
"Although Iowa is a farming state, its rates of non-Hodgkin lymphoma are close to the national average," added Lynch, who also is a University of Iowa professor of epidemiology. "This indicates that farming is not a major risk factor for this disease."
Non-Hodgkin lymphoma originates in a subset of white blood cells called lymphocytes, which are part of the body's immune system. The disease can occur in people of all ages and swell lymph nodes, create masses and cause weight loss and fatigue.
"Non-Hodgkin lymphoma is a spectrum of diseases that share similarities but also can be separated into subtypes that are increasingly being found to have unique risk factors and to respond to different therapies," Lynch said.
Some subtypes of non-Hodgkin lymphoma are among the most aggressive of all cancers, while other subtypes are so slow growing, they do not even need immediate treatment, noted George Weiner, M.D., director of the Specialized Program for Research Excellence (SPORE) in lymphoma research at the University of Iowa and head of Holden Comprehensive Cancer Center at the UI.
The University of Iowa's lymphoma SPORE, funded by the National Cancer Institute, is one of only three lymphoma SPORE grant programs in the country. Experts at Mayo Clinic work with the UI as part of the UI SPORE grant. More than 2,000 patients participate in the SPORE.
"A primary goal of the SPORE is to understand how lymphoma treatments work and how to improve them," Weiner said "We are making significant progress in the treatment of non-Hodgkin lymphoma due partly to figuring out how to use the immune system to fight this cancer.
Anti-lymphoma monoclonal antibodies are extremely helpful in treating many lymphoma patients, but not in others, Weiner said. One project supported by the SPORE focuses on understanding these differences by exploring in detail how antibodies direct the patient's own immune system to attack the lymphoma. Another is evaluating how inborn differences in the immune system impact on how well the antibodies work.
"This SPORE research is leading to new approaches to using current antibodies and to the design of stronger antibodies that we hope will be better than those currently available. This research could have an impact on other cancers, as well," Weiner said.
More than 150 hospitals, clinics and medical laboratories across Iowa, as well as referral facilities in neighboring states, contribute data to the State Health Registry of Iowa. The registry is one of 17 registries nationwide that currently are funded to provide data to the National Cancer Institute. Iowa's registry staff includes 50 members, half of whom are located throughout the state and help collect data from many facilities. The registry has been gathering cancer incidence and follow-up data for the state since 1973.
To learn more about non-Hodgkin lymphoma, visit the National Cancer Institute at http://www.cancer.gov/cancertopics/types/non-hodgkin.
To learn more about the University of Iowa and Mayo Clinic Specialized Program of Research Excellence in lymphoma based at the University of Iowa, visit http://www.uihealthcare.com/depts/cancercenter/research/ncispore.html.
University of Iowa Health Sciences
5141 Westlawn
Iowa City, IA 52242
United States
http://www.uiowa.edu
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