CLDA Establishes Research Collaboration
December 22, 2009Clinical Data, Inc. Establishes Research Collaboration to Study Genetic Variants Associated
with Response to Clopidogrel
Focus on proprietary genetic biomarkers in predicting Plavix(R) response -
NEWTON, Mass.--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(R)). 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," 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(R)
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(R) and PGxPredict(R) 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.
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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
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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 Cardio

