Health & Fitness
Health and Fitness
Health and Fitness
Wed, December 23, 2009
Tue, December 22, 2009 Clinical Data, Inc. Establishes Research Collaboration to Study Genetic Variants Associated with Response to Clopidogrel
NEWTON, Mass.--([ BUSINESS WIRE ])--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.1 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.2 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.3 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.
About PGxHealth®
PGxHealth, a division of Clinical Data, Inc., is utilizing its biomarker expertise and intellectual property to develop and commercialize targeted therapeutics as well as genetic and pharmacogenomic tests that detect serious diseases and help to predict drug safety and efficacy. By using innovative technologies and working with some of the world's most prestigious genomics thought leaders and institutions, PGxHealth is focused on improving clinical outcomes and reducing treatment costs in disease states and therapeutic classes with expensive, inefficient or suboptimal treatment options. Its tests are marketed under the FAMILION® and PGxPredict® brands. For more information, please visit PGxHealth's website at [ www.pgxhealth.com ].
About Clinical Data, Inc.
Clinical Data develops first-in-class and best-in-category therapeutics. The Company is advancing its late-stage drug candidates for [ central nervous system disorders ] and [ cardiovascular diseases ], to be followed by promising drug candidates in other major therapeutic areas. Clinical Data is also combining its drug development and biomarker expertise to develop products with enhanced efficacy and tolerability to improve patient health and reduce costs. To learn more, please visit the Company's website at [ www.clda.com ].
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains certain forward-looking information and statements that are intended to be covered by the safe harbor for forward looking statements provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)", "feel(s)", "believe(s)", "will", "may", "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements about our ability to obtain regulatory approval for, and successfully introduce our new products; our ability to expand our long-term business opportunities; financial projections and estimates and their underlying assumptions; and all other statements regarding future performance.All such information and statements are subject to certain risks and uncertainties, the effects of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to, risks related to whether Stedivaze or any of our therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration and equivalent foreign regulatory agencies and for which indications; whether Stedivaze or any of our other therapeutic products will be successfully marketed if approved; the development of and our ability to take advantage of the market for pharmacogenetic and biomarker products and services; and those risks identified and discussed by Clinical Data in its filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward looking statements that speak only as of the date hereof.Clinical Data does not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures in Clinical Data's SEC periodic and interim reports, including but not limited to its Annual Report on Form 10-K for the fiscal year ended March 31, 2009, Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2009, and Current Reports on Form 8-K filed from time to time by the Company.
1Sibbing D et al (2009) J Am Coll Cardiol. 53:849-56 ; Matetzky S et al (2004) Circ 109:3171-3175; Gurbel PA et al (2005) 46:1827-1832; Hochholzer W et al (2006) J Am Coll Cardiol 48:1742-1750; Price MJ et al (2008) Eur Heart J 29:202-207
2Sibbing D et al (2009) J Am Coll Cardiol. 53:849-56 ; Price MJ et al (2008) Eur Heart J 29:202-207; Cuisset T (2009) Am J Cardiol 104:1078-82
3Mega et al (2009) NEJM (2009) Jan 22;360(4):354-62; Simon T et al (2009) NEJM Jan 22;360(4):363-75; Collet JP et al (2009) Lancet Jan 24;373(9660):309-17; Sibbing et al (2009) Eur Heart J. Apr;30(8):916-22
