VARIAGENICS to Conduct Pharmacogenomic Evaluation of Major Cardiovascular Trial in Collaboration With Brigham & Women's Hospital
CAMBRIDGE, Mass.--(BW HealthWire)--July 30, 2002--VARIAGENICS, INC. (Nasdaq: VGNX - News), an emerging molecular diagnostics company and a leader in pharmacogenomics, today announced that it has entered into a research collaboration with Brigham & Women's Hospital (Boston, MA) and Paul M. Ridker, M.D., M.P.H., Director of Brigham & Women's Center for Cardiovascular Disease Prevention. Under the collaboration, VARIAGENICS will apply its genotyping and haplotyping platforms and statistical analysis methodology to the PRINCE (Pravastatin Inflammation CRP Evaluation) study to explore the contribution of genetic variability to variations in patients' therapeutic responses to pravastatin, a major cholesterol-lowering agent. VARIAGENICS will receive an exclusive option to license intellectual property resulting from the research, which may lead to the future development of cardiovascular diagnostic tests.
"This collaboration with Brigham & Women's Hospital represents a significant step forward in applying rigorous pharmacogenomic analysis to a large patient population within the context of a clinical trial," commented Jay Mohr, President and Chief Business Officer of VARIAGENICS. "Our expertise in marker discovery and analysis will be invaluable as we work with the PRINCE research team to conduct this unique pharmacogenomic study in a major disease area."
Pharmacogenomic analysis of the 2,884 PRINCE subjects' DNA samples may clarify the mechanism of action of statins, the leading class of cholesterol-lowering medications, with respect to both their anti-inflammatory and hypolipidemic actions. Specifically, the study will attempt to identify significant associations between variation in genes relevant to statin activity and the magnitude of cholesterol and C-reactive protein (CRP)-lowering, which is known to vary widely among patients. The discovery of genetically defined patient groups with different levels of inflammatory response to pravastatin could have dramatic implications for the use of the statin class of drugs, which may be indicated for over 100 million patients in developed countries.
"We are excited to be moving forward with this important pharmacogenomic project," Dr. Ridker noted. "If successful, we will learn a great deal about individual variation in inflammation and cholesterol metabolism, two processes critical to the development of heart attacks and stroke, both of which can be prevented by statin therapy."
The PRINCE study was a randomized, double-blind, placebo-controlled trial completed in 2000. The trial enrolled 2,884 subjects in two arms. The first arm evaluated 1,702 patients with no prior history of cardiovascular disease that were randomly assigned to receive 24-weeks of pravastatin 40 mg or placebo. The second arm studied 1,182 patients with a history of coronary artery disease that received 40 mg of pravastatin for 24 weeks. The primary endpoint of this clinical study was the change in CRP levels over the course of the 24-week treatment regimen. The study showed a 17% decrease in CRP in patients treated with pravastatin, compared with patients treated with the placebo. Thus, the results of the PRINCE study strengthen the hypothesis that statins have an anti-inflammatory effect, but as with the lipid-lowering effects, the responses varied among study participants.
About Brigham & Women's Hospital
Brigham & Women's Hospital is a 716-bed, nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare System, an integrated health care delivery network. Internationally recognized as a leading academic health care institution, BWH is committed to excellence in patient care, medical research, and the training and education of health care professionals. The hospital's preeminence in all aspects of clinical care is coupled with its strength in medical research. A leading recipient of research grants from the National Institutes of Health, BWH conducts internationally acclaimed clinical, basic and epidemiological studies.
About Variagenics
VARIAGENICS, INC. applies its pharmacogenomic technologies to the discovery, development and commercialization of personalized drugs and companion molecular diagnostic products focused primarily in the cancer area. The Company identifies therapeutically important genetic markers, including SNPs, haplotypes and, for cancer studies, loss-of-heterozygosity (LOH) and other related indicators. This information is then applied to clinical programs to enhance the success rates of drugs in development, and ultimately to the creation of diagnostics for predicting patient overall response to drugs. |
