Healthcare Industry News: depressive disorder
News Release - March 13, 2008
Clinical Data, Inc. Initiates Second Pivotal Phase III Study of Vilazodone
Second Pivotal Trial to Support a New Drug Application (NDA) for VilazodoneStudy to Further Evaluate Biomarkers of Drug Response
NEWTON, Mass.--(HSMN NewsFeed)--Clinical Data, Inc. (NASDAQ:CLDA ), a leader in the development of targeted therapeutics and predictive tests from its growing portfolio of proprietary genetic biomarkers, today announced that it has initiated the second of its two pivotal trials of Vilazodone, the Company’s novel drug candidate for the treatment of depression. This double-blind, placebo-controlled clinical trial is designed to assess the efficacy and safety of Vilazodone. It will also further evaluate genetic biomarkers of response to Vilazodone, which may lead to the development of a pharmacogenetic test that would help determine the likelihood of a patient’s positive response to the drug.
These biomarkers were identified during the first, successful pivotal trial of Vilazodone. In September 2007, Clinical Data announced that Vilazodone demonstrated both statistical and clinical significance on primary and secondary endpoints for efficacy in its first pivotal trial. Along with the long term safety study of Vilazodone that began in December 2007, the second pivotal trial is intended to support a new drug application (NDA) for Vilazodone. Clinical Data is on-track to file its NDA with the U.S. Food & Drug Administration in 2009.
“Multiple, peer-reviewed studies have been published in 2008 that point to the limited efficacy of currently available antidepressants and that validate the thesis that individuals respond differently to various antidepressents,” said Drew Fromkin, President and CEO of Clinical Data. “In the US alone, over 17 million people a year are prescribed one or multiple antidepressants. We believe that pharmacogenetics is essential for addressing the unmet need for reliable drug response, which could lead to decreased therapeutic and medical costs.”
“Clinical Data’s PGxHealthTM division focuses on the use of genetic biomarkers associated with drug response to guide physicians and patients to the drug or drug class that is most likely to be effective,” he added. “This is one approach to ‘personalized medicine’ that is gaining increased support from health insurers and is an integral part of PGxHealth’s development approach for Vilazodone.”
The trial will enroll approximately 475 adult patients diagnosed with Major depressive disorder at 10 US centers. As in the already completed Phase III study, the primary endpoint will be the mean change from baseline in the Montgomery-Asberg Depression Rating Scale total score compared to placebo.
About Vilazodone
Vilazodone is a dual serotonergic Phase III compound that Clinical Data is developing in parallel with genetic biomarkers to guide its use in the treatment of depression. It is both a Selective Serotonin Reuptake Inhibitor 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 pharmacogenetic test with Vilazodone to assist physicians in matching patients with a treatment that is more likely to be effective. 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. According to the Company's estimates, antidepressants generated sales of more than $12 billion in 2006 in the U.S. It is believed that some people may be genetically predisposed to depression and that it may be possible to identify genetic biomarkers to help predict the likelihood of a patient's pharmacological response to a given antidepressant.
About PGxHealth™
PGxHealth is a leader in the development of targeted therapeutics and predictive tests from its growing portfolio of proprietary genetic biomarkers. This division of Clinical Data has extensive experience and capabilities in the development, clinical validation and delivery of genetic tests that assist providers in targeting efficacious and safe drugs for their patients. PGxHealth also leverages its capabilities and intellectual property to develop therapeutics which are targeted at patient subpopulations where drug response is enhanced. Through its 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 treatment options. It has branded its genetic tests based on these proprietary genetic markers as Therapeutic Diagnostics™. For more information about PGxHealth, please visit its website at www.pgxhealth.com.
About Clinical Data, Inc.
Clinical Data, Inc. is a global biotechnology company unlocking the potential of molecular discovery, From Targeted Science to Better HealthcareTM. Its PGxHealthTM division focuses on proprietary biomarker and pharmacogenetic test development as well as targeted therapeutics to help predict drug safety and efficacy, thereby reducing health care costs and improving clinical outcomes. Its CogenicsTM 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. Visit the company’s website at www.clda.com for more information.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT 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 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; 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 for the fiscal year ended March 31, 2007, Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2007, and Current Reports on Form 8-K filed from time to time by the Company.
Source: Clinical Data Inc
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