Clinical Data Initiates Patient Enrollment for Vilazodone Phase 3 Clinical Trial; Top-line Data Anticipated in Mid-2007.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 ), 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 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. 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. 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 (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ). The vilazodone Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. 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 Major depressive disorder A mood disorder characterized by profound feelings of sadness or despair. Mentioned in: Conduct Disorder 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 (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. , 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 in·di·vid·u·al·ize tr.v. in·di·vid·u·al·ized, in·di·vid·u·al·iz·ing, in·di·vid·u·al·iz·es 1. To give individuality to. 2. To consider or treat individually; particularize. 3. treatment for depression." The Company notes that recently, the New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. (NEJM NEJM New England Journal of Medicine ) published results of a long-term, multi-center study of patients who failed treatment with 14 weeks of 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 (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 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. 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 reuptake /re·up·take/ (re-up´tak) reabsorption of a previously secreted substance. re·up·take n. 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 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 (SSRI) and a 5HT1A partial agonist agonist /ag·o·nist/ (ag´ah-nist) 1. one involved in a struggle or competition. 2. agonistic muscle. 3. . 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 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 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 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 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 |
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