• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Clinical Data Initiates Patient Enrollment for Vilazodone Phase 3 Clinical Trial; Top-Line Data Anticipated in Mid-2007

Posted on: Thursday, 30 March 2006, 12:00 CST

Clinical Data, Inc. (NASDAQ: CLDA), a worldwide leader in providing comprehensive molecular and pharmacogenomics services as well as clinical diagnostics to improve patient care, announced today that it has initiated patient enrollment in a pivotal Phase 3 clinical research study of vilazodone, a novel dual serotonergic antidepressant compound being studied for treatment of depression. The Company anticipates having initial results from this study available by mid-2007 and anticipates at least one long-term safety study and one additional pivotal study will be required prior to filing a New Drug Application (NDA).

The vilazodone Phase 3 clinical trial is a double-blind, placebo-controlled study designed to assess the safety and efficacy of vilazodone for the treatment of depression. The trial will enroll approximately 400 adult patients diagnosed with Major Depressive Disorder at eight U.S. centers. As part of the trial, Clinical Data will also seek to discover genetic markers for response to vilazodone. Potential biomarkers will be examined for each clinical subject, and the genetic analysis will be performed in-house by Clinical Data's GLP- and CLIA-approved facilities.

Clinical Data's President and CEO, Israel M. Stein, M.D., said, "We are pleased to advance vilazodone into a Phase 3 clinical trial. We believe this study will demonstrate that vilazodone is an effective compound for the treatment of depression and, in addition, will generate a genetic database that will be unique in the development of an anti-depressant. The biomarkers we expect to discover in patients treated with vilazodone will enable physicians to identify a population of patients most likely to respond to the drug leading to an individualized treatment for depression."

The Company notes that recently, the New England Journal of Medicine (NEJM) published results of a long-term, multi-center study of patients who failed treatment with 14 weeks of an SSRI (reflecting a high failure rate of nearly 50% of first line SSRI therapy). These patients were entered into one of two follow up treatment regimens. In the first regime, reported by Rush et al., patients were randomized to one of three alternative therapies. In the second regime, reported by Trivedi et al., the effects of augmentation therapy (adding a second agent to the original SSRI) were assessed. These studies determined that both alternative and augmented SSRI therapies increased remission of depression symptoms but with success rates of only 20-30%.

Carol Reed, M.D., Senior Vice President and Chief Medical Officer of Clinical Data, said, "These recently published studies clearly demonstrate that more effective therapies are needed for the treatment of depression. Vilazodone is unique in that it is a dual serotonergic antidepressant that provides for selective serotonin reuptake inhibition and partial 5HT1A agonism. The addition of biomarkers that select for response can position vilazodone as a unique therapy in the treatment of depression."

About Vilazodone

Vilazodone is a novel, dual serotonergic antidepressant. It is both a Selective Serotonin Reuptake Inhibitor (SSRI) and a 5HT1A partial agonist. The compound has been assessed in 15 phase 1 and five phase 2 trials involving a total of 369 healthy subjects and 1163 depressed patients. Vilazodone has been found to have an acceptable safety profile for this stage of development. In previous trials with positive controls, vilazodone failed to demonstrate significant efficacy against placebo but demonstrated efficacy comparable to that of the positive controls, approved antidepressants in wide use. The rights to develop and commercialize vilazodone were acquired from Merck KGaA in September 2004.

About Clinical Data, Inc.

Clinical Data, Inc. is a worldwide leader in providing comprehensive molecular and pharmacogenomics services as well as clinical diagnostics to improve patient care. Clinical Data's Therapeutic Diagnostics(TM) division, PGxHealth, builds upon existing assets acquired from Genaissance Pharmaceuticals in the areas of genomics-based, clinical diagnostics, therapeutic efficacy and safety biomarker development for drug utilization. PGxHealth plans to develop and introduce novel Therapeutic Diagnostics in combination with new and existing therapeutics. Clinical Data's Pharmacogenomics and Molecular Services(TM) division, Cogenics, consolidates the operations of Genaissance Pharmaceuticals, Inc., Lark Technologies, Inc. and Icoria, Inc., each acquired during 2005, and Genome Express SA, acquired in 2006. Cogenics provides a comprehensive range of molecular and pharmacogenomics services to pharmaceutical, biotech, academia, agricultural, and government clients. These services are offered in both research and regulated environments and have applications across the lifecycle of pharmaceutical product development including pharmacovigilance requirements post-launch. Clinical Data's Vital Diagnostics division consolidates the operations of Clinical Data Sales & Service, Inc., Vital Scientific NV, Vital Diagnostics Pty. Ltd., and Electa Lab s.r.l. This division serves the clinical laboratory in the traditional in-vitro diagnostics market worldwide with a focus on the physician's office, hospital and small-to-medium sized laboratory segments. With customers in approximately 100 countries, Vital Diagnostics has achieved a leading market share for instruments and reagents sold into moderately complex physicians' office laboratories within the United States.

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 recent 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. Such 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 Clinical Data will be able to develop or acquire additional products and attract new business and strategic partners; competition from pharmaceutical, biotechnology and diagnostics companies; the strength of our intellectual property rights; the effect on the Company's operations and results of significant acquisitions or divestitures made by major competitors; the Company's ability to achieve expected synergies and operating efficiencies in all of its acquisitions, and to successfully integrate its operations; and those risks discussed and identified by Clinical Data in its public 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 reports, including but not limited to its Annual Report on Form 10-KSB for the fiscal year ended March 31, 2005, and fiscal 2005 and 2006 quarterly reports on Forms 10-QSB and 10-Q.

Internet Website: www.clda.com

Source: Business Wire

More News in this Category