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December 20, 2004

Genaissance Identifies Genetic Markers Implicated In Fatal Side Effects Of Schizophrenia Drug

Topics: Clinical Pharmacology

"Findings Underscore Role of Pharmacogenetics In Managing Safety Outcomes Of Drugs That Cause Serious Side Effects In Defined Populations."  Genaissance has issued a press release today announcing the discovery of genetic markers that the Company believes predict patients who are at risk of developing clozapine-induced agranulocytosis, a life-threatening decrease of white blood cells that requires frequent blood testing of patients.

New Haven, CT, December 20, 2004 - Genaissance Pharmaceuticals, Inc. (Nasdaq: GNSC) today announced results from its CARING (Clozapine and Agranulocytosis Relationships Investigated by Genetics) study, reporting the discovery of genetic markers that the Company believes predict who is at risk of developing clozapine-induced agranulocytosis, a life-threatening decrease of white blood cells that requires frequent blood testing of patients. The Company said the findings may apply to other drugs that also affect white blood cell counts.

"In light of recent drug withdrawals and labeling restrictions due to rare but serious adverse drug events, these results underscore the potential of pharmacogenetics to identify individuals who are at particular risk for developing fatal adverse drug reactions," said Kevin Rakin, President and Chief Executive Officer of Genaissance. "The CARING study is a powerful, cost-effective model for understanding the contribution of genetics to other adverse drug reactions and provides strong evidence of the power of Genaissance's proprietary platform. We believe an appreciable market exists for a genetic diagnostic test for predicting which patients are at-risk for developing agranulocytosis in response to clozapine and other drugs"

"Our analyses indicate that genetic variation appears to explain a significant portion of the risk of developing clozapine-induced agranulocytosis," added Carol R. Reed, M.D., Vice President of Medical Affairs of Genaissance. "We believe the sensitivity and selectivity of these markers could support further development of a diagnostic test. Additionally, one of the associations we identified in the HLA (Human Leukocyte Antigen) complex has been previously reported to be associated with clozapine-induced agranulocytosis. Our results confirm this finding, building confidence that our novel findings will be validated in future studies."  Continue reading Press release (upper left on Co.site)

It will be interesting to study other pharmacogenetic applications such as in Cox-2 inhibitors, especially since it is most often the case that serious side effects usually occur in small subsets of patient populations.

Posted by Hyscience at December 20, 2004 12:53 PM



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