Clinical Data Participates in MAb IMPACT Meeting to Improve Clinical Efficacy of Monoclonal Antibodies for Cancer Treatment.Focus on FCGR3A Pathway for Optimizing MAb-based Therapies Complements Company's Oncology Program NEWTON, Mass. -- PGxHealth([R]), a division of 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 ), today announced its participation in the international mAb IMPACT meeting which is focused on IMProving ACTivation of the FCGR3A pathway for optimizing the treatment of cancer. At this meeting, funded by the French Institut National du Cancer and supported by leading academic and industry organizations including PGxHealth, experts will discuss how genetic variation in the FCGR3A pathway can be employed to improve clinical outcomes in the treatment of lymphomas, breast and colorectal cancers with rituximab, trastuzumab and cetuximab, respectively, and other recombinant monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). (mAbs). This effort complements PGxHealth's FCGR program, which includes its PGxPredict([TM]):RITUXIMAB, a test for genetic variation in the FCGR3A gene that can be used to determine response to rituximab monotherapy in the treatment of follicular fol·lic·u·lar adj. 1. Relating to, having, or resembling a follicle or follicles. 2. Affecting or growing out of a follicle or follicles. non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma . "The approach of applying pharmacogenetics Pharmacogenetics Definition Pharmacogenetics is the study of how the actions of and reactions to drugs vary with the patient's genes. Description to develop drugs and predictive tests based on a critical pathway, such as FCGR3A, offers greater opportunity for us to understand the mechanisms of action of monoclonal antibodies and to discover new and enhanced cancer therapies," said Herve Watier, Ph.D., Professor of Immunology, University of Tours The University of Tours, also known as the Université François Rabelais, is a public university in Tours, France. The university is named after the French writer François Rabelais, and was founded in 1969. , France, and a lead organizer of the mAb IMPACT conference. "FCGR genotyping Genotyping refers to the process of determining the genotype of an individual with a biological assay. Current methods of doing this include PCR, DNA sequencing, and hybridization to DNA microarrays or beads. in drug development is becoming an important tool for maximizing therapeutic benefit and we look forward to additional commercial applications and further clinical research in this area." FCGR3A is a gene that encodes an Fc gamma receptor that binds IgG1 antibodies, both natural and therapeutic. The FCGR3A receptor transmits signals from the membrane into the cell via tyrosine kinase tyrosine kinase An enzyme intimately linked to signal transduction–ST, either as a receptor-type TK, which participates in transmembrane signaling, or as an intracellular TK, participating in ST to the nucleus; ↑ or ↓ TK activity is associated with activity. This signaling pathway is important to antibody-dependent cellular cytotoxicity cytotoxicity /cy·to·tox·ic·i·ty/ (si?to-tok-sis´i-te) the degree to which an agent possesses a specific destructive action on certain cells or the possession of such action. (ADCC ADCC antibody-dependent cell-mediated cytotoxicity. ADCC antibody-dependent cell-mediated cytotoxicity. ), a mechanism critical to the efficacy of therapeutic mAbs. The results of recent studies suggest that genotyping FGCR3A and other Fc gamma receptors may be important in predicting response to cetuximab in colorectal cancer and to trastuzumab in breast cancer1,2. "We are pleased to be a part of this first-of-a-kind meeting focused on the Fc gamma receptor pathway and its impact on the efficacy of monoclonal antibody-based cancer therapies," said Carol R. Reed, M.D., Chief Medical Officer of Clinical Data. "This significant undertaking by international oncology experts affirms our own strategy to develop predictive tests for cancer which are based on the Fc gamma receptor and IgG1 antibodies. We aim to contribute to advancements in this area by establishing research collaborations with thought leaders in oncology in order to enhance our PGxPredict:RITUXIMAB test and expand our Fc gamma receptor program to include other existing and emerging mAb-based cancer therapies." For more information about the mAb IMPACT meeting on November 20-21, 2008 in Tours, France, please contact Herve Watier at herve.watier@univ-tours.fr. About PGxPredict([TM]):RITUXIMAB PGxHealth's PGxPredict:RITUXIMAB test detects a single nucleotide polymorphism Noun 1. single nucleotide polymorphism - (genetics) genetic variation in a DNA sequence that occurs when a single nucleotide in a genome is altered; SNPs are usually considered to be point mutations that have been evolutionarily successful enough to recur in a (rs396991, 4985G>T) in FCGR3A that has been found to independently predict the response of patients with follicular non-Hodgkin's lymphoma to treatment with rituximab monotherapy. For more information, please contact 877-2-PGxHealth (877-274-9432) or visit www.pgxhealth.com. About PGxHealth([R]) PGxHealth has extensive experience and capabilities in the development, clinical validation and delivery of genomics-based tests. 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 disease states and therapeutic classes with expensive, inefficient or suboptimal Suboptimal A solution is called suboptimal if a part of the solution has been optimized without regards to the overall objective. treatment options. Among its tests are the FAMILION and the PGxPredict([R])brands. Visit the company's website at www.pgxhealth.com. About Clinical Data, Inc. Clinical Data is a global biotechnology company unlocking the potential of molecular discovery, From Targeted Science to Better Healthcare([R]). The Company's PGxHealth division is utilizing its biomarker intellectual property to develop and commercialize a broad pipeline of targeted therapeutics as well as pharmacogenetic tests that help predict drug safety and efficacy, thereby reducing health care costs. Its Cogenics([R])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. Please visit the Company's website at www.clda.com for more information. 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 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, whether our PGxPredict[TM] tests, including but not limited to FAMILION, will gain wide acceptance in the market; the extent to which genetic markers (haplotypes) are predictive of clinical outcomes and drug efficacy and safety; 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 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, 2008, Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the fiscal quarter ended September 30, 2008, and Current Reports on Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 8-K. filed from time to time by the Company. 1 Zhang W et al. Journal of Clinical Oncology The Journal of Clinical Oncology is a medical journal published by the American Society of Clinical Oncology. The Journal was founded in 1983 and publishes original research and review articles on topics relating to cancer. It is published 3 times a month. . 2007 Aug 20;25(24):3712-8. 2Musolino A et al. Journal of Clinical Oncology. 2008 Apr 10;26(11):1789-96. |
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