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Clinical Data and George Washington University Establish Relationship to Examine Impact of Genetic Testing in Warfarin Treatment

Posted on: Thursday, 19 July 2007, 15:11 CDT

The PGxHealth division of Clinical Data, Inc. (NASDAQ: CLDA), and The George Washington University Medical Faculty Associates Department of Orthopaedic Surgery today announced that they have established a relationship to examine the integration of genomic testing in warfarin treatment.

The program will be implemented in an orthopaedic practice setting during a patient's normal course of treatment, enrolling 80 patients who have been prescribed the blood thinner warfarin as a treatment measure following orthopaedic surgery. Of those 80 patients, a randomly-assigned half will have their warfarin dose determined with the help of PGxPredict™:WARFARIN in order to evaluate the potential clinical, safety and treatment-time benefits of using the genetic test to determine optimal warfarin dosing. The program has already received approval from the University Institutional Review Board and is open to enrollment. If the program results are positive, pharmacogenetic testing could be incorporated into the Clinic's routine practice.

"Warfarin is a drug with both valuable benefits and serious risks, so it is an ideal candidate for assessing whether pharmacogenetic testing can improve patient outcomes and reduce treatment costs," said Dr. Carol Reed, Clinical Data's Chief Medical Officer. "Clinical Data and the GW Medical Faculty Associates hope to assess the value of tests such as PGxPredict™ WARFARIN in a typical practice setting. Combined with its proprietary genetic tests for clozapine safety and rituximab efficacy, Clinical Data seeks to transform advances in molecular biology into clinical products to benefit patients, physicians and payers."

"The optimal maintenance dose of warfarin for each patient is difficult to predict at the beginning of treatment, requiring frequent monitoring before a stable maintenance dose is established," said Dr. Andrew Holmes, Principal Investigator and Assistant Professor of Orthopaedic Surgery at GW . "Since our joint replacement patients are only prescribed warfarin for a few weeks, it is important to get the dose right the first time and to avoid complications such as intraarticular hemorrhage. Tools such as the PGxPredict™: WARFARIN test could offer doctors a more precise method for determining a patient's warfarin regimen, while helping to reduce the potentially serious outcomes that warfarin presents. The GW Medical Faculty Associates is excited about the potential to better manage the incidence of adverse effects for our patients."

Test Contact Information:

Kerri Holick Ph.D., Product Lead, PGxPredict:WARFARIN Test

1-877-2-PGXHEALTH (877-274-9432)

warfarininfo@pgxhealth.com

About PGxPredict: WARFARIN

PGxPredict: WARFARIN test predicts how individual patients will respond to warfarin, a well-established anti-clotting agent often prescribed after cardiovascular events such as heart attack and stroke, for prophylaxis of clot formation in the setting of major surgery, and for the treatment of other clotting disorders. By helping doctors quickly and accurately establish the correct dose, the test may:

Increase warfarin's efficacy

Reduce the risk of serious side effects, including life-threatening bleeding

Help patients achieve faster recovery

About Warfarin

More than two million patients in the United States take warfarin to prevent blood clotting after cardiovascular events such as heart attack and stroke, after major surgery, or for the treatment of clotting disorders. Despite its established efficacy, warfarin dosing remains a challenge due to serious side effects. Too high a dose can lead to life-threatening bleeding, while under-dosed warfarin can fail to prevent recurrent thromboembolic episodes. Between one and seven out of every 100 warfarin patients will experience major bleeding episodes.

In November 2005, The Clinical Pharmacology Subcommittee of the Food and Drug Administration (FDA) Advisory Committee for Pharmaceutical Sciences strongly advocated for the inclusion of genotype information in the prescribing of warfarin.

About PGxHealth

PGxHealth™ has extensive experience and capabilities in the development, clinical validation and delivery of genomic-based tests, in particular of efficacy and safety biomarkers for appropriate drug utilization. Through its own know-how and resources, work conducted with some of the world's most prestigious genomics thought leaders and institutions, and use of innovative technologies, PGxHealth is focused on reducing treatment costs and improving clinical outcomes in those disease states and therapeutic classes beset with expensive, inefficient or suboptimal treatment options. It has branded its genetic tests based on these proprietary genetic markers Therapeutic Diagnostics™.

About Clinical Data, Inc.

Clinical Data, Inc. is a global biotechnology company unlocking the potential of molecular discovery, from targeted science to better healthcare. Its PGxHealth division focuses on genetic test and biomarker development to help predict drug safety and efficacy, thereby reducing health care costs and improving clinical outcomes. Its Cogenics division provides molecular and pharmacogenomics services to both research and regulated environments. Its Vital Diagnostics division offers in vitro diagnostics solutions for the clinical laboratory. 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.

About The George Washington University Medical Faculty Associates

The GW Medical Faculty Association is a non-profit, 501(c) (3) physician group practice corporation comprising the academic clinical faculty of The George Washington University Medical Center. In its seventh year of existence, the MFA has gown to include over 280 physicians providing medical care in 41 specialty areas. The MFA's mission is to provide excellence and expertise in patient care, medical education and scientific, clinical research. The MFA is responsible for the medical education of nearly 700 Medical Students, more than 400 interns, residents and fellows while treating an average of 1,500 patients a day. The MFA is the largest and most comprehensive multi-specialty practice group in the District of Columbia that is conveniently located in a 316,000 square-foot facility.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

This press release contains certain forward-looking information about Clinical Data that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. 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 regarding: 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; our ability to maintain normal terms with our customers and partners; financial projections and estimates and their underlying assumptions; and statements regarding future performance. All of such statements are subject to certain risks and uncertainties, many 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: whether our PGxPredict tests will gain wide acceptance in the market; the extent to which genetic markers (haplotypes) are predictive of clinical outcomes and drug efficacy and safety; our ability to achieve the expected synergies and operating efficiencies from all of our acquisitions; 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; general economic downturns; and other risks contained in our various SEC reports and filings, including but not limited to our Annual Report on Form 10-K for the fiscal year ended March 31, 2007, and our subsequent Current Reports on Form 8-K filed with the 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, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Internet Website: www.clda.com

Source: Business Wire

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