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Clinical Data Secures EU Patent for MDR1
Thursday, June 26, 2008
Gene Linked to Response to Many Classes of Medications
Newton, MA -- Clinical Data, Inc. (Nasdaq: CLDA), a leader in the development of targeted therapeutics and predictive tests from its growing portfolio of proprietary genetic biomarkers, announced today that the European Patent Office has granted Patent No. 1232260 to Bernried, Germany-based Epidauros Biotechnologie AG, a wholly-owned subsidiary of Clinical Data, relating to the use of a genetic variant, or biomarker, of the gene MDR1 (also known as ABCB1), which encodes P-glycoprotein (PGP). PGP is an efflux pump expressed in the gut and kidneys but also by tumor cells, and therefore modulates the response to medications by blocking their absorption into the body or into tumors. Classes of drugs transported by PGP include chemotherapeutics, immunosuppressants, and protease inhibitors.
Genetic testing of MDR1 variation has become an increasingly important part of many drug discovery and development efforts. The particular variant covered by the patent issued to Epidauros, C3435T, is the most common variant of MDR1, occurring in approximately 50% of Caucasians and in 20% and 40% of people of African and Asian descent, respectively. C3435T is part of the newly launched Affymetrix Drug Metabolizing Enzymes and Transporter (DMET) Early Access solution, currently the world's most comprehensive method for assaying the genetics of drug metabolism. Clinical Data´s Cogenics® division supported Affymetrix in its development and commercialization of this technology.
"With the acquisition of Epidauros in August 2007, Clinical Data’s PGxHealth® division gained a rich portfolio of genetic biomarkers for drug metabolism and transport, and we have made significant progress in unlocking its value," said Drew Fromkin, President and CEO of Clinical Data. "The issuance of this European patent for MDR1 and its use as part of a new standardized panel for routine pharmacokinetic analysis are important milestones in this effort. We are actively pursuing opportunities to develop predictive tests for drug response with this proprietary MDR1 variant as additional data further validate its clinical utility in a number of therapeutic indications."
The European Patent Office also recently granted Patent No. 135835 to Epidauros which relates to the detection of the *7 allele of the CYP3A5 gene. CYP3A5 regulates an enzyme known to metabolize many common, frequently prescribed drugs -- including statins, calcium channel blockers, and HIV protease inhibitors. The *7 allele is most commonly found in people of African descent, where the frequency of *7 is as high as 20%.
About Clinical Data, Inc.
Clinical Data, Inc. is unlocking the potential of molecular discovery from Targeted Science to Better Healthcare™. Its PGxHealth® division focuses on proprietary biomarker and pharmacogenetic test development as well as targeted therapeutics to help predict drug safety and efficacy, thereby reducing health care costs and improving clinical outcomes. Its Cogenics® division provides genomics services to both research and regulated environments. Through these divisions, Clinical Data is leveraging advances in molecular discovery to provide tangible benefits for patients, doctors, scientists and health plans worldwide. Visit the Company's website at www.clda.com for more information.
Safe Harbor Statement
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 successfully integrate the operations, business, technology and intellectual property obtained in our acquisitions; 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 statements regarding future performance. All of 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, the strength of our intellectual property rights; competition from pharmaceutical, biotechnology and diagnostics companies; the development of and our ability to take advantage of the market for pharmacogenetic and biomarker products and services; whether Clinical Data will be able to develop or acquire additional products and attract new business and strategic partners; 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, 2008 and Current Reports on Form 8-K filed from time to time by the Company.
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