Pharmaceutical Business review

PGxHealth Enters Into Research Collaboration With Clinical Data

PGxHealth, a division of Clinical Data, has entered into a research collaboration with Deutsches Herzzentrum (DHZ) to evaluate the predictive value of genetic markers, including PGxHealth proprietary markers, for response to clopidogrel (Plavix).

Reportedly, 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.

As per the collaboration, researchers are expected to 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.

Additionally, several known genetic variants and Clinical Data’s proprietary markers is also expected to be evaluated for association with risk of cardiovascular events in patients taking clopidogrel.

Researchers will also seek to identify genetic predictors of clopidogrel response. Platelet function data from a subset of patients will also be analysed, providing a second, direct measure of clopidogrel response. Preliminary data from the studies is anticipated in 2010.

Dirk Sibbing, principal investigator of the study at Deutsches Herzzentrum, said: “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.

“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.”

Marcia Lewis, vice president of biomarker development at PGxHealth, said: “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. 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.”