Clinical Data Announces 2006 Launch of Genetic Test for Warfarin Response; Company Licenses Intellectual Property Relating to Genetic Testing for Warfarin Response -Two Genes Help Predict More Than 50% of Warfarin Response Variability.NEWTON, Mass. -- More Than 2 Million Patients in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. Take Warfarin to Treat or Prevent Blood Clotting blood clotting, process by which the blood coagulates to form solid masses, or clots. In minor injuries, small oval bodies called platelets, or thrombocytes, tend to collect and form plugs in blood vessel openings. Associated with Stroke and Other Cardiovascular Events Clinical Data, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CLDA CLDA California Lyme Disease Association ), a worldwide leader in providing comprehensive molecular and pharmacogenomics services as well as genetic tests to improve patient care, announced today that its PGxHealth(TM) division will provide a genetic test to clinicians that is associated with response to warfarin, a commonly prescribed drug to treat and prevent blood clots Blood Clots Definition A blood clot is a thickened mass in the blood formed by tiny substances called platelets. Clots form to stop bleeding, such as at the site of cut. associated with stroke, heart attack, and other clotting disorders. The ability to provide this test is a direct result of Clinical Data's recent execution of intellectual property licenses under which the Company has been granted commercialization rights relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc certain polymorphisms in the Vitamin K epoxide reductase Vitamin K epoxide reductase (VKOR) is an enzyme (EC 1.1.4.1) that reduces vitamin K after it has been oxidised in the carboxylation of glutamic acid. Its C1 subunit (VKORC1) is the target of anticoagulant warfarin.[1][2] References 1. complex gene (VKORC VKORC Vitamin K Epoxide Reductase Complex 1; also known as VKOR VKOR Vitamin K Epoxide Reductase ). Polymorphisms within the VKORC1 gene are one of the important predictors of response to warfarin. Clinical Data notes that assessment of warfarin metabolism based on certain polymorphisms in the well-known CYP CYP In currencies, this is the abbreviation for the Cyprus Pound. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 2C9 gene accounts for about 17% of the variability in warfarin dosing while analysis of the VKORC1 gene polymorphisms accounts for an additional 15% of the variability. When combined with certain clinical parameters, more than 50% of the variability in response to warfarin can now be explained. It is anticipated that PGxHealth will make this test commercially available by year-end 2006. (Reference: Sconce, et al The impact of CYP2C9 and VKORC1 genetic polymorphism polymorphism, of minerals, property of crystallizing in two or more distinct forms. Calcium carbonate is dimorphous (two forms), crystallizing as calcite or aragonite. Titanium dioxide is trimorphous; its three forms are brookite, anatase (or octahedrite), and rutile. and patient characteristics upon warfarin dose requirements: proposal for a new dosing regimen. Blood, 1 October 2005, 106: 2329 - 2333.) Drew Fromkin, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , explained, "Warfarin is commonly prescribed for the treatment and prevention of blood clotting, but dosing is a challenging process requiring frequent monitoring to achieve a stable maintenance dose. A seemingly innocuous dose has the potential to be too much for some patients putting them at risk for serious hemorrhage while being sub-therapeutic in other patients leaving them at risk for thromboembolism thromboembolism /throm·bo·em·bo·lism/ (-em´bo-lizm) obstruction of a blood vessel with thrombotic material carried by the blood from the site of origin to plug another vessel. throm·bo·em·bo·lism n. that could lead to stroke or heart attack. We believe there is a compelling case to be made for the introduction of a genetic test for warfarin response given the time and resources devoted to monitoring patients being treated with warfarin and the significant value associated with optimizing patient outcomes through the appropriate use of this drug. Taking these licenses is a necessary step to commercializing this test as well as protecting our franchise and partnerships long term." Carol Reed, M.D., Senior Vice President and Chief Medical Officer, said, "Recently discovered polymorphisms in the VKORC1 gene, the target of warfarin, interfere with the metabolism of warfarin. By licensing the underlying IP for VKORC1, PGxHealth is now able to put this new information together as a comprehensive warfarin genetic test. The improved test should, when combined with certain clinical information, explain or predict more than 50 percent of the variability in response to 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, for prophylaxis prophylaxis (prō'fĭlăk`sĭs), measures designed to prevent the occurrence of disease or its dissemination. Some examples of prophylaxis are immunization against serious diseases such as smallpox or diphtheria; quarantine to confine of clot formation in the setting of major surgery and for the treatment of other clotting disorders. Despite its popularity and well-established efficacy, warfarin dosing for an intended therapeutic outcome remains challenging as this drug poses significant risks and can have serious side effects Side effects Effects of a proposed project on other parts of the firm. including life-threatening bleeding. In addition, the optimal maintenance dose of warfarin for each patient is difficult to predict at the beginning of treatment, and it can take a month or more of frequent monitoring of the prothrombin time Prothrombin Time Definition The prothrombin time test belongs to a group of blood tests that assess the clotting ability of blood. The test is also known as the pro time or PT test. (PT, a test for blood coagulability coagulability /co·ag·u·la·bil·i·ty/ (ko-ag?u-lah-bil´it-e) the capability of forming or of being formed into clots. coagulability the state of being capable of forming or of being formed into clots. ) before a stable maintenance dose of warfarin is identified. Changes in the PT may not always reflect only a change in warfarin dose because diet, concomitant medication and environmental factors can each influence PT test results. In contrast, genetic information on the pharmacokinetic and pharmacodynamic properties of response to warfarin is not affected by such external factors. It is anticipated that the PGxHealth warfarin test will provide clinicians with an understanding of how an individual patient will respond to warfarin. About Clinical Data, Inc. Clinical Data, Inc. is a worldwide leader in providing comprehensive molecular and pharmacogenomics services as well as genetic tests to improve patient care. The Company, founded in 1972, is organized under three worldwide divisions segmented by service offerings and varying client constituents: PGxHealth(TM); Cogenics(TM); and Vital Diagnostics(TM). Clinical Data's Therapeutic Diagnostics(TM) division, PGxHealth, builds upon existing assets and know-how acquired from Genaissance Pharmaceuticals in the areas of genomics-based, genetic tests and therapeutic efficacy and safety biomarker development for drug utilization. PGxHealth plans to develop and introduce novel Therapeutic Diagnostics in some instances in combination with new and existing therapeutics. Clinical Data's Pharmacogenomics and Molecular Services(TM) division, Cogenics, consolidates the operations of Genaissance Pharmaceuticals, Inc., Lark Technologies, Inc. and Icoria, Inc., each acquired during 2005, and Genome Express SA, acquired in 2006. Cogenics provides a comprehensive range of molecular and pharmacogenomics services to pharmaceutical, biotech, academia, 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. Clinical Data's Vital Diagnostics division consolidates the operations of Clinical Data Sales & Service, Inc., Vital Scientific NV, Vital Diagnostics Pty. Ltd., and Electa Lab s.r.l. This division 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. With 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 currently employs a staff of over 430. The Company is headquartered in Newton, Massachusetts with operations in Texas, Connecticut, RTP (1) (Rapid Transport Protocol) The protocol used in IBM's High Performance Routing (HPR) system. (2) (Realtime Transport Protocol) An IP protocol that supports real time transmission of voice and video. - North Carolina North Carolina, state in the SE United States. It is bordered by the Atlantic Ocean (E), South Carolina and Georgia (S), Tennessee (W), and Virginia (N). Facts and Figures Area, 52,586 sq mi (136,198 sq km). Pop. , Rhode Island Rhode Island, island, United States Rhode Island, island, 15 mi (24 km) long and 5 mi (8 km) wide, S R.I., at the entrance to Narragansett Bay. It is the largest island in the state, with steep cliffs and excellent beaches. , and California as well as internationally in the UK, France, the Netherlands, Italy and Australia. Furthermore, Clinical Data has numerous distribution, licensing, development and other collaborations with key partners. SAFE HARBOR Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 |
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