PGxHealth, DHZ announce collaboration in genetic variant study with response to clopidogrel

PGxHealth, a division of Clinical Data, Inc. (NASDAQ: CLDA), today announced that it has established a research collaboration with Deutsches Herzzentrum (DHZ), Munich, Germany, to evaluate the predictive value of genetic markers, including PGxHealth proprietary markers, for response to clopidogrel (Plavix^®). Variability in clopidogrel response is a well established phenomenon and several studies have demonstrated that poor response is associated with increased risk of cardiovascular events. PGxHealth scientists will collaborate with researchers at DHZ to conduct one of the largest retrospective case/control studies to date to validate genetic variants associated with response to clopidogrel.

“Combining our efforts with PGxHealth will allow us to further evaluate genetic variants in a very large, clopidogrel-treated patient population with coronary stent placement, which includes a substantially greater number of cases than previous studies”

“Combining our efforts with PGxHealth will allow us to further evaluate genetic variants in a very large, clopidogrel-treated patient population with coronary stent placement, which includes a substantially greater number of cases than previous studies,” said Dirk Sibbing, M.D., Principal Investigator of the study, Deutsches Herzzentrum. “We expect these results to be extremely valuable for guiding antiplatelet therapy in the future and for determining which genetic variants predict the clinical outcome in clopidogrel-treated patients and which do not.”

Under the collaboration, researchers will examine samples selected from a large cohort of clopidogrel-treated patients that have undergone percutaneous coronary intervention (PCI) and may be at high risk for cardiovascular events if they don’t respond appropriately to clopidogrel. Several known genetic variants and Clinical Data’s proprietary markers will be evaluated for association with risk of cardiovascular events in patients taking clopidogrel. Researchers will also seek to identify novel genetic predictors of clopidogrel response. Platelet function data from a significant subset of patients will also be analyzed, providing a second, direct measure of clopidogrel response. Preliminary data from the studies is anticipated in 2010.

“While the role of CYP2C19 in poor response to clopidogrel is widely known, it is clear that this gene does not account for all the variability in response,” said Marcia Lewis, Vice President, Biomarker Development at PGxHealth. “Dr. Sibbing and his colleagues at DHZ are at the forefront of cardiovascular research and this collaboration will expand our knowledge, as well as support the development of a test that is highly predictive of individual response to clopidogrel.”

Polymorphisms in several genes, including CYP2C19 and other cytochrome P450 enzymes involved in clopidogrel metabolism, have been associated with inadequate response to clopidogrel. Of these, only the CYP2C19*2 association is well established. There has recently been heightened interest in a genetic test that will predict how a patient will respond to clopidogrel due to the increased risk of often serious adverse clinical outcomes associated with poor response. In addition, the recent availability of new antiplatelet therapies has further fueled interest in a test to guide selection of appropriate antiplatelet drug.