Clinical Data Completes Phase III Enrollment of Vilazodone for Depression.On Schedule for Q3 2007 Assessment of Top-Line Efficacy and Genetic Biomarker Results 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 Division has completed enrollment in a pivotal Phase III study of Vilazodone, in development for the treatment of depression. This randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, placebo-controlled trial was launched in the first quarter of 2006 and has now reached its target with dosing of 410 patients with major depressive disorder Major depressive disorder A mood disorder characterized by profound feelings of sadness or despair. Mentioned in: Conduct Disorder major depressive disorder enrolled at ten investigative sites. This is one of two pivotal trials required for a new drug application, which the Company hopes to file with the United States Food & Drug Administration (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. ) in 2009. In conjunction with this study, Clinical Data is analyzing genetic biomarkers that may correlate with the prediction of response to Vilazodone. The Company anticipates announcing top-line efficacy and genetic biomarker results in the third calendar quarter of 2007. Carol R. Reed, M.D., the Company's Chief Medical Officer, said, "The treatment of depression is currently hampered by overall poor response to first-line treatment options. As demonstrated in the STAR*D STAR*D Sequenced Treatment Alternatives to Relieve Depression study1, response rates of less than 50% are the norm. Vilazodone has a novel mechanism of action based on its dual serotonergic se·ro·to·ner·gic or se·ro·to·ni·ner·gic adj. Activated by or capable of liberating serotonin, especially in transmitting nerve impulses. serotonergic containing or activated by serotonin. properties as an SSRI SSRI selective serotonin reuptake inhibitor. SSRI n. Selective serotonin reuptake inhibitor; a class of drugs that inhibit the reuptake of serotonin in the central nervous system, used to treat depression and other and 5HT1A partial agonist. This molecule would be the first of its kind in the market. With the addition of genetic markers that predict higher response rates in targeted populations, Vilazodone may prove to be an even more effective therapy for depressed patients." 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. of Clinical Data, added, "We are very pleased to have completed enrollment for this Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the and look forward to communicating the results. We also are applying our demonstrated expertise in developing and commercializing pharmacogenetic tests towards the development of a PGxPredict[TM] test for Vilazodone response. Such a test, in combination with the drug's unique properties in managing depression, has the potential to significantly improve patient outcomes and reduce costs over those currently experienced with existing drugs." About Vilazodone Vilazodone is a dual serotonergic antidepressant antidepressant, any of a wide range of drugs used to treat psychic depression. They are given to elevate mood, counter suicidal thoughts, and increase the effectiveness of psychotherapy. in pivotal Phase III clinical trials that Clinical Data is developing with a companion biomarker which will act as a genetic-based, predictive screening tool to guide the use of this novel antidepressant. It is both a Selective Serotonin Reuptake Inhibitor selective serotonin reuptake inhibitor n. SSRI. Selective serotonin reuptake inhibitor (SSRI) A class of antidepressants that work by blocking the reabsorption of serotonin in the brain, raising the levels of and a 5HT1A partial agonist that has been found to have an acceptable safety profile for this stage of development. As approximately one-half of depressed patients do not achieve satisfactory results with current first-line treatment options, Clinical Data hopes to develop a product that combines a genetic test with Vilazodone to assist physicians in matching patients with a treatment that is likely to work for that patient in the first instance. The worldwide rights to develop and commercialize Vilazodone were acquired from Merck KGaA of Darmstadt, Germany, in September 2004. About Depression and the Antidepressant Market The Surgeon General's Office estimates that 5.3% of American adults, approximately 17 million people, suffer from depressive illness. In 2004 according to IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. , the treatment of this illness generated sales of more than $9.75 billion in antidepressants Antidepressants Medications prescribed to relieve major depression. Classes of antidepressants include selective serotonin reuptake inhibitors (fluoxetine/Prozac, sertraline/Zoloft), tricyclics (amitriptyline/ Elavil), MAOIs (phenelzine/Nardil), and heterocyclics . While many patients derive significant benefit from currently available therapies, the extent to which the benefit is due to the pharmacology of a particular drug is unknown in most cases because the 'placebo' effect in clinical trials for depression is often significant. A 2002 meta-analysis of 47 clinical studies comparing antidepressants against placebo2 suggests that a significant proportion of patients on antidepressant therapies are benefiting not from the drug but from a placebo effect placebo effect n. A beneficial effect in a patient following a particular treatment that arises from the patient's expectations concerning the treatment rather than from the treatment itself. . It is believed, however, that some people may be genetically predisposed to depression (and one or more of its etiologies) and that it may be possible to identify certain genetic biomarkers that might help to predict the likelihood of a patient's pharmacological response to a given antidepressant. About PGxHealth PGxHealth[TM] has extensive experience and capabilities in the development, clinical validation and delivery of genomic-based tests, in particular in the areas 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 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 and biotech companies and academics institutions in 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 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 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 Vilazodone will advance further in the clinical trials process and whether and when, if at all, Vilazodone will receive final approval from the U.S. Food and Drug Administration and equivalent foreign regulatory agencies and for which indications; whether Vilazodone will be successfully marketed if approved; 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 December 31, 2006, filed with the SEC on February 14, 2007, and our 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 1 Sequenced Treatment Alternatives to Relieve Depression study, funded by NIMH 2 Kirsch kirsch n. A colorless brandy made from the fermented juice of cherries. [French, short for German Kirschwasser; see kirschwasser. I, Moore T, et al. The emperor's new drugs: an analysis of antidepressant medication data submitted to the U.S. Food and Drug Administration. Prevention and Treatment. 2002; 5:1-11 |
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