CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sept. 26, 2002--VARIAGENICS, INC. (Nasdaq: VGNX - News), an emerging molecular diagnostics company and leader in pharmacogenomics, today announced the launch of its program to develop molecular diagnostic tests predictive of the response of solid tumors to chemotherapy. The first clinical study will involve genetic analysis of over 100 patients who have experienced severe side effects following 5-fluorouracil (5-FU) chemotherapy for colorectal cancer. A retrospective study has been started with Dr. Andre van Kuilenburg from the Laboratory of Genetic Metabolic Diseases at the Academic Medical Center (AMC) in Amsterdam.
"This study is an important milestone for VARIAGENICS and constitutes the first step in creating clinically and commercially important molecular diagnostics," said Joseph S. (Jay) Mohr, VARIAGENICS' President and Chief Business Officer. "In analyzing these samples we will be utilizing our pharmacogenomic platforms and taking advantage of our intellectual property portfolio surrounding the antimetabolite pathway."
Almost 150,000 new cases of colorectal cancer are diagnosed annually in the United States alone. 5-FU based regimens have been the standard treatment for advanced colorectal cancer for 35 years, despite their low efficacy (30% at best) and high toxicity: approximately 20% of patients suffer severe adverse reactions to standard 5-FU/leucovorin (LV) protocols, with 1-5% of patients requiring hospitalization.
The goal of this study with AMC is to identify and confirm markers predictive of toxicity through retrospective analysis of polymorphisms in the normal DNA of patients who have exhibited severe toxic reactions following 5-FU based chemotherapy, including fatal gastrointestinal and central nervous system reactions. The study will focus on selected 5-FU/LV pathway genes in which VARIAGENICS has already identified a total of more than 200 polymorphisms. VARIAGENICS will provide Dr. van Kuilenburg with polymorphism data and his laboratory will provide Variagenics with DNA and clinical data from patients who have experienced severe 5-FU toxicity. Once Variagenics has completed genetic analysis of the samples from AMC, both Dr. van Kuilenburg and VARIAGENICS will perform statistical analysis to potentially identify specific patient genotypes associated with toxicity.
"I am very excited about this opportunity to extend the work of Dr. van Kuilenburg's laboratory exploring the genetic basis for 5-FU toxicity beyond studies of dihydropyrimidine dehydrogenase (DPD). In this collaboration, we will use VARIAGENICS' data and expertise on the 5-FU/leukovorin pathway genes which will be part of a larger endeavor that could improve the way we treat cancer," said Vince Stanton, M.D, VARIAGENICS' Vice President of Research and Principal Scientist.
VARIAGENICS' product development program has the long-term goal of developing a suite of molecular diagnostics to guide optimal treatment of colorectal cancer. The ability to assess the likely toxicity and efficacy of commonly prescribed chemotherapeutics for an individual would provide clinicians with a powerful tool to use when deciding among therapeutic options. In addition to this study with AMC, VARIAGENICS intends to collaborate with other leading cancer investigators to conduct both retrospective and prospective clinical studies involving 5-FU, irinotecan (CPT-11), and oxaliplatin. ,,, |
