Clinical Data Launches Pharmacogenetic Test for Clozapine-Induced Agranulocytosis on Schedule.PGxPredict:CLOZAPINE clozapine /clo·za·pine/ (klo´zah-pen) a sedative and antipsychotic agent; used in the treatment of schizophrenia. clo·za·pine n. ([TM]) to Aid Physicians in Determining Patients' Risk for Developing Agranulocytosis agranulocytosis (əgrăn'yəlōsītō`sis), disease in which the production of granulated white blood cells by the bone marrow is impaired. 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 its PGxHealth[TM] division, provider of Therapeutic Diagnostics[TM], has launched a new test, PGxPredict:CLOZAPINE[TM], a pharmacogenetic test designed to aid physicians prescribing or considering prescribing clozapine. This is the first of several tests that Clinical Data intends to release this year, again demonstrating its ability to develop, validate and commercialize proprietary, pharmacogenetic tests in the ever-evolving field of pharmacogenetics Pharmacogenetics Definition Pharmacogenetics is the study of how the actions of and reactions to drugs vary with the patient's genes. Description . The PGxPredict:CLOZAPINE test will provide information on whether a patient is at Higher or Lower Risk of developing clozapine-induced agranulocytosis (CIA CIA: see Central Intelligence Agency. (1) (Confidentiality Integrity Authentication) The three important concerns with regards to information security. Encryption is used to provide confidentiality (privacy, secrecy). ) compared to the untested population. The test is intended to be used as an adjunct to existing clinical information to aid in determining the risk of developing CIA and in determining the risk-benefit ratio of treatment with clozapine. As demonstrated in the CATIE CATIE Centro Agronómico Tropical de Investigación y Enseñanza (Costa Rica) CATIE Canadian Aids Treatment Information Exchange CATIE Clinical Antipsychotic Trials of Intervention Effectiveness (Clinical Antipsychotic Trials for Interventions Effectiveness) study, clozapine, a generic, relatively inexpensive atypical antipsychotic, is one of the most effective treatments for treatment-resistant schizophrenia. "I am excited to have contributed to the development of this test," said Stanton Gerson, M.D., Shiverick Professor of Hematological hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. Oncology and Director of the Ireland Cancer Center at University Hospitals Case Medical Center. "It can be used by psychiatrists and hematologists alike in both the ongoing management of patients already being treated with clozapine and in the assessment of patients being considered for clozapine treatment. I am looking forward to this test becoming available as well as to additional refinements through continued research by PGxHealth. It is my hope that this information may lead someday to reduced blood monitoring requirements and broader use of this very effective medication for treating schizophrenia." PGxPredict:CLOZAPINE places patients into one of two categories: Higher Risk or Lower Risk, through the analysis of a simple blood sample and the genotyping of two single nucleotide polymorphisms in the gene HLADQB1. This gene has been shown by PGxHealth to be associated with CIA in 2 independent case-control cohorts. Based on these studies, Higher Risk patients have a 2.5 relative risk of developing CIA in comparison to general clozapine-treated patients, while Lower Risk patients have a 0.5 relative risk. "Today we prescribe to an individual based on what is expected from studies of large heterogenous (spelling) heterogenous - It's spelled heterogeneous. populations and watch to see how the patient responds," said Carol Reed, Chief Medical Officer of Clinical Data. "With PGxPredict tests, doctors can make more informed treatment decisions specific to each patient. Based on the results of this test, physicians will be able to prescribe clozapine with more confidence and patients will have greater comfort that they can take this efficacious drug safely." For more information on the PGxPredict:CLOZAPINE test, call 1-877-2-CIA-TEST (877-224-2837) or email ciatestinfo@pgxhealth.com. PGxHealth provides the following genetic tests to practitioners: FAMILION([R]), a genetic test designed to identify mutations in people with inherited cardiac channelopathies such as Long QT Syndrome The long QT syndrome (LQTS) is a heart condition associated with prolongation of repolarisation (recovery) following depolarisation (excitation) of the cardiac ventricles. It is associated with syncope (fainting) and sudden death due to ventricular arrhythmias. (LQTS LQTS Long QT interval syndrome, see there ) and Brugada Syndrome; PGxPredict: WARFARIN, a pharmacogenetic test that measures variation in 2 genes related to response to warfarin; and a pharmacogenetic assay that tests for mutations in the thiopurine S-methyl transferase transferase /trans·fer·ase/ (trans´fer-as) a class of enzymes that transfer a chemical group from one compound to another. trans·fer·ase n. (TPMT TPMT Thiopurine Methyltransferase TPMT Transaction Processing Monitor Technology TPMT Total Preventive Maintenance Time ) gene, exclusively licensed from St. Jude Children's Research Hospital St. Jude Children's Research Hospital, founded in 1962, is a leading pediatric treatment and research facility focused on children's catastrophic diseases. It is located in Memphis, Tennessee. In 1996, Peter Doherty, Ph.D., of St. and offered through Prometheus Laboratories Inc. and Specialty Laboratories (a wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. of Ameripath, Inc.), that provides an assessment of a patient's ability to 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 thiopurine class of drugs, prescribed in a wide range of therapeutic areas including oncology, rheumatology rheumatology /rheu·ma·tol·o·gy/ (-tol´ah-je) the branch of medicine dealing with rheumatic disorders, their causes, pathology, diagnosis, treatment, etc. rheu·ma·tol·o·gy n. , organ transplantation and vasculitis Vasculitis Definition Vasculitis refers to a varied group of disorders which all share a common underlying problem of inflammation of a blood vessel or blood vessels. The inflammation may affect any size blood vessel, anywhere in the body. . About Clozapine Phase II of the CATIE study confirmed that clozapine was more effective than other atypical antipsychotics for patients who had previously discontinued from a different atypical antipsychotic treatment. However, clozapine is a third-line treatment option for schizophrenia. In part, this is because of the risk of CIA which occurs in an estimated 1.3% of patients based on pre-market data with no prospective blood monitoring. The requirement for blood monitoring, as described on the clozapine package insert, has reduced the incidence of CIA to 0.3-0.4%. The use of PgxPredict:CLOZAPINE does not eliminate the need for monitoring of white blood cell counts and absolute neutrophil counts as recommended in clozapine prescribing information. About PGxHealth PGxHealth[TM] 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 Suboptimal A solution is called suboptimal if a part of the solution has been optimized without regards to the overall objective. treatment options. It has branded its genetic tests based on these proprietary genetic markers Therapeutic Diagnostics[TM]. 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 In vitro diagnostic (IVD) tests are medical tests conducted in a test tube, or more generally in a controlled environment outside a living organism. In vitro means in glass in Latin. 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. SAFE HARBOR 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 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, 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 |
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