Clinical Data Launches PGxPredict(TM):RITUXIMAB on Schedule.Pharmacogenetic Test to Aid Physicians in Managing Therapy for Patients with 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 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[TM]:RITUXIMAB, further strengthening its leadership position within the rapidly evolving fields of pharmacogenetics Pharmacogenetics Definition Pharmacogenetics is the study of how the actions of and reactions to drugs vary with the patient's genes. Description and molecular diagnostics. This is the second pharmacogenetic test of its kind launched by PGxHealth this month. The assay is based on a worldwide exclusive license to an intellectual property portfolio from Innate Pharma S.A. of Marseille, France. PGxPredict:RITUXIMAB is a pharmacogenetic test that helps physicians predict the likelihood of a given patient responding to rituximab monotherapy in the treatment of follicular non-Hodgkin's lymphoma (NHL NHL Non-Hodgkin's lymphoma, see there ). This test allows oncologists to identify whether a patient is among the 20% of people that will demonstrate a stronger likelihood of responding to rituximab. "PGxPredict:RITUXIMAB is the third PGxPredict test that Clinical Data has launched in the last four months. We are very pleased and excited that we can bring pharmacogenetic tests like these to market rapidly and provide physicians with more information when making important clinical decisions with their patients," said Drew Fromkin, 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. of Clinical Data. "For the first time in this life-threatening disease, physicians can consider the genetic makeup of each patient in evaluating the likelihood of response to rituximab. Having this information will assist physicians when considering treatment options." This new genetic test will provide unique and valuable information for patients with follicular NHL and their doctors. By analyzing a person's DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. from a blood sample, the test identifies 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 , referred to as V158F, in the FCGR3A gene. This gene encodes the Fc gamma IIIa receptor on lymphocytes to which rituximab binds. Based on two independent studies in 49 and 87 patients, respectively, patients with follicular, CD20-positive, B-cell NHL who carried the 158V/V v/v volume (of solute) per volume (of solvent). v/v volume (of solute) per volume (of solvent). version of the variant in the FCGR3A gene were more likely to respond to rituximab monotherapy than patients with other variants. This association held true when response was measured at both 2-month and 12-month end points.1,2 In addition, functional characterization of this variant has shown altered binding affinity of IgG1 antibodies, including rituximab, to the Fc gamma IIIa receptor.3 Based on this published data, approximately 20% of patients will carry the 158V/V variant and will be identified by the PGxPredict:RITUXIMAB test as more likely to respond (estimated response rate of 90%). Approximately half of those who do not carry the 158V/V variant may still respond to rituximab monotherapy. The assay will detect the variant with over 99% accuracy, based on the method validation performed by the testing laboratory, Cogenics, Inc., a subsidiary of Clinical Data. While rituximab has proven to be valuable in the treatment of patients with follicular, CD20-positive NHL, its high cost of approximately $12,000 for four weekly treatments, and risk of toxicity may make the choice to prescribe or maintain therapy with rituximab a difficult one for physicians and patients, especially with other treatment options available. The PGxPredict:RITUXIMAB test will provide unique and valuable information to physicians and patients as they evaluate their treatment options. For more information on the PGxPredict:RITUXIMAB test, please visit http://www.pgxhealth.com or call 1-877-4-RITUXIMAB (877-474-8894) or email rituximabtestinfo@pgxhealth.com. About Follicular NHL and Rituximab Globally, NHL is the sixth leading cause of new cancer cases with the incidence rising and estimated to be 5.6 per 100,000 persons, though the incidence varies geographically.4 NHL has the highest incidence in the United States, Australia and New Zealand, and Europe. The incidence in the United States is 17.1 per 100,000 with approximately 22% of all cases of NHL belonging to the follicular subtype.4,5 Rituximab (Rituxan([R]), Genentech and Biogen Idec) is an IgG1 immunotherapeutic agent indicated for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma, for the first line treatment of follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in combination with CVP CVP central venous pressure. CVP abbr. central venous pressure CVP central venous pressure. CVP Central venous pressure, see there chemotherapy, for the treatment of low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy and for the first-line treatment of diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma in combination with CHOP or other anthracycline-based chemotherapy regimens. Rituximab costs approximately $12,000 for a 4-week course of treatment for NHL, although insurance companies typically pay a significant portion of the cost. Per the rituximab package insert, the overall response rate to monotherapy is 57% at week 8 with weekly dosing in relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL. In patients receiving single agent rituximab for treatment of relapsed or refractory, low grade or follicular NHL, Grade 3 and 4 adverse events overall were reported in 57% of patients treated with 4 weekly doses and in 70% of patients treated with 8 weekly doses of rituximab. See package insert for full prescribing information. Rituximab is sold as Rituxan in the United States. All trademarks are property of their respective owners. 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]. In addition to PGxPredict:RITUXIMAB, 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[TM]:WARFARIN, a pharmacogenetic test that measures variation in 2 genes related to response to warfarin; 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 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. ; and PGxPredict[TM]:CLOZAPINE clozapine /clo·za·pine/ (klo´zah-pen) a sedative and antipsychotic agent; used in the treatment of schizophrenia. clo·za·pine n. , a pharmacogenetic test designed to aid physicians prescribing or considering prescribing clozapine that will provide information on whether a patient is at Higher or Lower Risk of developing clozapine-induced agranulocytosis agranulocytosis (əgrăn'yəlōsītō`sis), disease in which the production of granulated white blood cells by the bone marrow is impaired. (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. 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. About Innate Pharma S.A. Innate Pharma S.A. (Euronext Paris: FR0010331421 - IPH IPH International Association of Paper Historians IPH Impressions Per Hour IPH International Paper Historians (paper watermark database) IPH Ipoh, Malaysia - Ipoh (Airport Code) ) is a biopharmaceutical company which develops first-in-class drugs to target innate immunity. The pioneering work of Innate Pharma's scientific founders and research groups has led to the development of three product platforms (gamma delta T cells, NK cells and TLR TLR Trailer TLR Toll Like Receptor (immunological research) TLR Temple (University) Law Review TLR Twin Lens Reflex TLR Texas Law Review TLR The Last Resort (gaming clan) ), each directly or indirectly validated in clinical oncology settings. In view of their mechanisms of action, Innate Pharma's drug candidates also have development potential in fields outside oncology, particularly in the treatment of infectious disease and chronic inflammation. The company's most advanced molecule is in Phase II clinical trials. With its strong scientific position in innate immunity pharmacology, its robust intellectual property portfolio and its R&D expertise, Innate Pharma intends to become a leading player in the rapidly growing market of immunotherapeutics. 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 References 1 Cartron G, Dacheux L, Salles G, Solal-Celigny P, Bardos P, Colombat P and Watier H. 2002. Therapeutic activity of humanized anti-CD20 monoclonal antibody and polymorphism in IgG Fc receptor Fc[eth][thorn]RIIIa gene. Blood, 99: 754-758. 2 Weng W-K W-K Wiener-Khinchine Relationship and Levy R. 2003. Two immunoglobulin G fragment C receptor polymorphisms independently predict response to rituximab in patients with follicular lymphoma. 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. , 21(21): 3940-3947. 3 Dall'Ozzo S, Tartas S, Paintaud G, Cartron G, Colombat P, Bardos P, Watier H, and Thibault G. 2004. Rituximab-dependent cytotoxicity by natural killer cells natural killer cells, n.pl lymphocytes that are part of innate immunity that kill foreign substances and abnormal tissues. Decreased number or activi-ty has been linked to a number of diseases, including AIDS, cancer, chronic fatigue syndrome, : Influence of FCGR3A polymorphism on concentration-effect relationship. Cancer Research, 64:4664-4669. 4 Ferlay J, Bray F, Pisani P and Parkin DM. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide IARC CancerBase No. 5. version 2.0, IARCPress, Lyon, 2004 5 Evans LS, and Hancock BW. 2003. Non-Hodgkin's Lymphoma. Lancet, 362:139-146. |
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