Clinical Data Announces License Agreements.License with Mayo Foundation for Medical Education and Research Enables Clinical Data's PGxHealth Division to Test for Mutations Associated with Adverse Reactions adverse reactions, n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration. to Irinotecan NEWTON, Mass. -- 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 ) announced today that it has entered into an agreement with Mayo Foundation for Medical Education and Research (Mayo Clinic Mayo Clinic: see Mayo, Charles Horace. Mayo Clinic voluntary association of more than 500 physicians in Rochester, Minnesota. [Am. Hist.: EB, 11: 723] See : Medicine ) granting Clinical Data, Inc. a license under a variety of patents and patent applications to provide testing of the UGT UGT abbr. urgent (telegram) 1A1 gene. The Company also announced that it has exclusively licensed to Mayo Clinic certain of its own UGT1A1-related patent rights. UGT1A1 is involved in metabolism of irinotecan (Camptosar), a commonly prescribed first-line treatment for advanced colo-rectal cancer. Though effective, irinotecan can cause dangerous or lethal reactions in up to 30 percent of the population due to the inability to properly metabolize me·tab·o·lize v. 1. To subject to metabolism. 2. To produce by metabolism. 3. To undergo change by metabolism. metabolize to subject to or be transformed by metabolism. the drug. The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has recently revised the labeling for Camptosar to recommend reduced dosing in patients who test homozygous ho·mo·zy·gous adj. Having the same alleles at one or more gene loci on homologous chromosome segments. Homozygous Identical genes controlling a specified inherited trait. for the *28 variant of UGT1A1. An estimated 145,000 new cases of colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. are diagnosed in the United States each year, making it the third most common cancer. Up to 50 percent of cases are candidates for irinotecan therapy. 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. , said, "By reaching this agreement with Mayo Clinic, Clinical Data is now among a select group of laboratories licensed to offer a pharmacogenomic test for UGT1A1*28. This important test marks our second pharmacogenomic assay in the oncology sector. Additionally, by out-licensing our own UGT1A1-related IP to Mayo Clinic, Clinical Data is enabling Mayo's Department of Laboratory Medicine and Pathology to continue further development of assays addressing this important pathway." 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[TM]; Cogenics[TM]; and Vital Diagnostics[TM]. The Pharmacogenomics and Molecular Services[TM] 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 molecular biology, scientific study of the molecular basis of life processes, including cellular respiration, excretion, and reproduction. The term molecular biology was coined in 1938 by Warren Weaver, then director of the natural sciences program at the Rockefeller 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[TM], 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 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. About Mayo Clinic The Department of Laboratory Medicine and Pathology at Mayo Clinic maintains an active diagnostic test development program. These activities also incorporate discoveries from other diagnostic and biotechnology companies and academic organizations. Mayo utilizes these proven diagnostic technologies in the care of its patients and offers them to more than 5,000 health care institutions around the world through Mayo Medical Laboratories (MML MML - Human-Machine Language. A language from ITU-T for telecommunications applications. It has a complex natural-language syntax. [CCITT Recommendations Z.311-Z.318, Z-341, Nov 1984]. ). Revenue from MML testing is used to support medical education and research at Mayo Clinic. 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-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the fiscal year ended March 31, 2006, and fiscal 2005, 2006, and 2007 quarterly reports on Forms 10-QSB and 10-Q. Internet Website: www.clda.com |
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