>>ORLANDO, Fla., Nov. 11 /PRNewswire-FirstCall/ -- Genaissance Pharmaceuticals, Inc. (Nasdaq: GNSC - News) today presented, at the American Heart Association's Scientific Sessions 2003, clinical data describing associations between genetic markers (HAP(TM) Markers) and response to treatment with the statin class of drugs. The two presentations provided additional results from Genaissance's Statin Response Examined by Genetic Haplotype Markers (STRENGTH) clinical study.
In one presentation, Genaissance confirmed an association between HAP(TM) Markers in the gene apolipoprotein E (ApoE) and levels of C-reactive protein (CRP), which has been associated with inflammation and linked to risk for arteriosclerosis. Genaissance also extended the association by identifying ApoE HAP(TM) Markers that are present in those patients who showed the greatest reduction in the level of CRP when treated with a statin.
"We believe that this finding could help predict which patients will experience the greatest anti-inflammation effect of statins, further reducing their risk for arteriosclerosis," said Richard S. Judson, Ph.D., Senior Vice President and Chief Scientific Officer of Genaissance Pharmaceuticals. "Our new findings, combined with our previously released data, provide the basis for new DNA-based diagnostic tests for the cardiovascular market that could be used to help physicians make dosing and other treatment decisions."
In the second presentation, Genaissance described an association between HAP(TM) Markers in the gene P-Selectin, which has been associated with diabetes and cardiovascular conditions, and changes in the level of HDL-Cholesterol (HDL-C) in response to statin therapy. The association was observed with all of the statins studied (atorvastatin, pravastatin and simvastatin) and represents an effect of the statin class of drugs. The HAP(TM) Markers also identified patients most likely to experience a reduction in HDL-C if switched to a higher dose of a statin.
"Having a high level of HDL-C is considered to be beneficial to one's health," said Dr. Judson. "We believe that genetic markers, such as those for P-Selectin, could aid a physician in treating a patient with the statin class of drugs so as to maximize the lowering of LDL-C, the bad cholesterol, while maintaining as high a level as possible of the good cholesterol, HDL-C."
The American Heart Association meeting is being held during the same week that the Federal Drug Administration (FDA) is holding a workshop (on November 13th), entitled "Pharmacogenomics in Drug Development and Regulatory Decision-Making: The Genomic Data Submission Proposal," to discuss guidelines for submission of Pharmacogenetic data to the FDA, including DNA-based diagnostic tests for use with drug therapy.
About HAP(TM) Markers
The term "HAP" is a trademark of Genaissance Pharmaceuticals and is derived from the technical term haplotype. A haplotype is a combination of nucleotides that are present at each of the polymorphic sites on a chromosome in selected regions of a gene.<<
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