Clinical Data Initiates Long-Term Safety Study For Vilazodone

Main Category: Depression
Also Included In: Clinical Trials / Drug Trials
Article Date: 19 Dec 2007 - 1:00 PDT

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Clinical Data, Inc. (NASDAQ: CLDA), a leader in the development of targeted therapeutics and predictive tests from a growing portfolio of proprietary genetic biomarkers, announced that it has initiated a long-term safety study for Vilazodone, the company's drug candidate for the treatment of depression, ahead of schedule. Along with a second pivotal Phase III trial that is on track to begin in the company's fiscal fourth quarter, ending on March 31, 2008, this safety study is intended to support a new drug application (NDA) for Vilazodone expected to be filed with the U.S. Food & Drug Administration in 2009.

Vilazodone has a novel dual mechanism of action, acting as both a potent selective serotonin-reuptake inhibitor (SSRI) and as a 5-HT1A partial agonist. Clinical Data is at the same time developing a pharmacogenetic test that would help determine the likelihood that a patient will respond favorably to Vilazodone.

"By launching this trial, Clinical Data continues to demonstrate its ability to independently move a promising compound through the development process," said Drew Fromkin, President and CEO of Clinical Data. "We are encouraged by the results of our recently completed pivotal study of Vilazodone, which suggests that it has important benefits as a stand-alone compound for patients with depression. With the addition of a genetic test for response to Vilazodone, we can help clinicians more quickly and confidently identify patients who are likely to respond, leading to improvements in patient care and outcomes. This is just one example of how pharmacogenetics can lead to more targeted therapeutics and therefore better healthcare. Clinical Data's expertise and portfolio of patented biomarkers positions the company to play a growing role in this area."

This current study will test the long-term safety and tolerability of Vilazodone and will enroll patients at 40 sites in the United States. A second pivotal trial will continue the evaluation of genetic biomarkers of response to Vilazodone that were identified in the first pivotal trial announced by the company in September 2007. That trial met its primary and supportive secondary endpoints for efficacy of Vilazodone in the treatment of major depressive disorder.

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 for each 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. 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 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 Clinical Data, Inc. for more information.

Safe Harbor Statement Under The Private Securities Litigation Reform Act 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 introduce our new pharmacogentic and molecular diagnostics products and services; 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; whether our PGxPredict™ pharmacogenomics tests and Cogenics molecular services offerings 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; general economic downturns; and other risks contained in our various SEC reports and filings, including but not limited to our Annual Report on Form 10-K for the fiscal year ended March 31, 2007, our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 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.

Clinical Data, Inc.