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Clinical Data Launches Pharmacogenetic Warfarin Response Test On Schedule

Posted on: Friday, 6 October 2006, 09:00 CDT

Clinical Data, Inc. (NASDAQ: CLDA), announced today that its PGxHealth™ division, a provider of Therapeutic Diagnostics™, has launched its PGxTest:WARFARIN™.

The PGxTest:WARFARIN is a pharmacogenetic test that measures variation in 2 genes. One gene, CYP2C9, metabolizes warfarin to an inactive metabolite; the second, VKORC1, encodes the enzyme that is the target of warfarin. Variants in these genes have been shown in multiple studies to correlate with warfarin dose requirements. A simple finger stick collects the sample for this test. Clinicians and payors may request prescribing information by calling 1-888-5-warfarin (1-888-592-7327) or going to www.warfarintest.com.

Carol Reed, M.D., Senior Vice President and Chief Medical Officer of Clinical Data, said, "By acquiring certain intellectual property rights and applying our core expertise in pharmacogenetics, PGxHealth is launching a pharmacogenetic test that may be used in conjunction with prescribing warfarin. There is wide inter-individual variability in the warfarin dose that each patient requires. While dose requirements are influenced by fluctuations in variables such as diet and co-prescribed therapeutics, the genetic influences are not affected by such external factors. The results of this test, when used in combination with other important clinical information, should reduce the guesswork in dose selection and enable more precise determination of the final dosing regimen."

More than two million patients in the United States take warfarin to prevent blood clotting 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. Despite its established efficacy, warfarin dosing remains challenging due to serious side effects including life-threatening bleeding that may occur if the dose is too high and failure to prevent recurrent thromboembolic episodes if the dose is too low. In addition, the optimal maintenance dose of warfarin for each patient is difficult to predict at the beginning of treatment and it can take several weeks of frequent monitoring before a stable maintenance dose of warfarin is established. The genetic variants tested in The PGxTest:WARFARIN have been shown to explain more than half of the variability in response to warfarin as measured by the prothrombin time, the standard measure of blood coagulation used to monitor warfarin's effect.1 The use of this test does not eliminate the need for monitoring prothrombin times as clinically indicated.

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 stating, "Sufficient mechanistic and clinical evidence exists to use lower doses of warfarin for patients with genetic variations in CYP2C9 that lead to reduced activity and genotyping patients in the induction phase of warfarin therapy would reduce adverse events and improve achievement of stable INR in patients with genetic variations in CYP2C9" and "Sufficient mechanistic and clinical evidence exists to use lower doses of warfarin for patients with genetic variations in VKORC1 that lead to reduced VKORC1 activity and genotyping patients in the induction phase of warfarin therapy would reduce adverse events and improve achievement of stable INR in patients with genetic variations in VKORC1."

About Clinical Data, Inc.

Clinical Data, Inc., a worldwide leader in providing comprehensive molecular and pharmacogenomics services as well as genetic tests to improve patient care, is organized under three worldwide divisions segmented by service offerings and varying client constituents: PGxHealth™; Cogenics™; and Vital Diagnostics™. The Pharmacogenomics and Molecular Services™ division, Cogenics, consolidates operations of Genaissance Pharmaceuticals, Inc., Lark Technologies, Inc., Icoria, Inc., and Genome Express SA to provide a comprehensive range of molecular biology and pharmacogenomics services to pharmaceutical, biotech, academic, agricultural, and government clients. These services are offered in both research and regulated environments and have applications across the lifecycle of pharmaceutical product development including pharmacovigilance requirements post-launch. PGxHealth builds upon existing assets and know-how acquired from Genaissance Pharmaceuticals, Icoria, and Genome Express in the areas of genomics-based, genetic tests and therapeutic efficacy and safety biomarker development for drug utilization. PGxHealth develops, validates and commercializes novel Therapeutic Diagnostics™, in some instances in combination with new and existing therapeutics, to improve patient care. In addition, PGxHealth has a therapeutic drug candidate, vilazodone, currently in late stage clinical trials for the treatment of depression. Vital Diagnostics serves the clinical laboratory in the traditional in-vitro diagnostics market worldwide. With a focus on the physician's office, hospital and small-to-medium sized laboratory segments and customers in approximately 100 countries, Vital Diagnostics has achieved a leading market share for instruments and reagents sold into moderately complex physicians' office laboratories within the United States. Clinical Data is headquartered in Newton, Mass. with operations in Texas, Connecticut, North Carolina, Rhode Island, and California as well as internationally in the UK, France, the Netherlands, Italy and Australia.

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 successfully integrate the operations, business, technology and intellectual property obtained in our recent 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. Such 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, whether Clinical Data will be able to develop or acquire additional products and attract new business and strategic partners; competition from pharmaceutical, biotechnology and diagnostics companies; the strength of our intellectual property rights; the effect on the Company's operations and results of significant acquisitions or divestitures made by major competitors; the Company's ability to achieve expected synergies and operating efficiencies in all of its acquisitions, and to successfully integrate its operations; and those risks discussed and identified by Clinical Data in its public 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 reports, including but not limited to its Annual Report on Form 10-KSB for the fiscal year ended March 31, 2005, and fiscal 2005 and 2006 quarterly reports on Forms 10-QSB and 10-Q.

Internet Website: www.clda.com

1 Sconce et al. The impact of CYP2C9 and VKORC1 genetic polymorphisms and patient characteristics upon warfarin dose requirements: proposal for a new dosing regiment. Blood (2005); 106: 2329-2333.

Source: Business Wire

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