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Clinical Data Initiates Pivotal Phase III Trial for Novel Antidepressant; First Ever Pharmacogenomic Screening Tool for Antidepressant to be Developed Concurrently.


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 commercializing pharmacogenomics to guide drug utilization, announced today that the Company will begin enrollment of a pivotal 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  for vilazodone, a novel compound being studied for treatment of depression, and anticipates having initial results from this study available by mid-2007. The successful outcome of this trial would serve as one of two pivotal trials required for 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 "), which the Company hopes to file with the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  Food & Drug Administration as early as year end 2008.

Carol R. Reed, M.D., the Company's Chief Medical Officer, said, "Following our recent meeting with the staff of the Division of Psychiatry Products of the 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.
 we are accelerating our development plans for vilazodone and a companion biomarker test. We believe this program has the potential to revolutionize the treatment of depression. As part of this trial, Clinical Data will use its expertise in biomarker discovery to identify biomarkers for response to vilazodone. We plan to use these biomarkers to develop a test to screen for patients who are likely to benefit from the drug. About half of depressed patients do not achieve satisfactory results with current first-line treatment options; we hope to assist physicians in matching a patient with a treatment that is likely to work for that patient. There are no such predictive tests currently available."

"This is a transformative event in the history of Clinical Data," said 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. "The development of a genetic-based, predictive screening tool to guide the use of a novel 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.  would represent a significant advance in pharmacogenomics and in the treatment of depression. While available therapeutics are many, a patient's response is highly 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.
, leading to trial-and-error inefficiencies and unnecessary delay in finding effective treatment."

About Vilazodone

Vilazodone is 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. 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 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 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 I and five phase II 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 control, an approved antidepressant in wide use. The rights to develop and commercialize vilazodone were acquired from Merck KGaA of Darmstadt, Germany, in September 2004.

Clinical Trial Design

This double-blind, placebo-controlled clinical trial is designed to assess the efficacy and safety of vilazodone and to discover genetic markers of treatment response associated with vilazodone. 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 US centers. Potential biomarkers will be examined for each clinical subject, and the genetic analysis will be performed in-house by the company at its GLP- and CLIA-approved facilities, which perform similar genetic services for many major pharmaceutical companies. At least one long-term safety study, which has yet to be reviewed by the FDA, will be required prior to NDA filing. The Company is hopeful that clinical subjects from each of the pivotal efficacy trials will participate in the long-term safety studies.

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 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
, 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.
.

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 placebo(1) 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 certain people may be genetically predisposed pre·dis·pose  
v. pre·dis·posed, pre·dis·pos·ing, pre·dis·pos·es

v.tr.
1.
a. To make (someone) inclined to something in advance:
 to depression (and one or more of its etiologies) and that it may be possible to predict, based on certain genetic biomarkers, the likelihood of a patient's pharmacological response to a given antidepressant.

About Clinical Data, Inc.

Clinical Data, Inc. is a worldwide leader in providing molecular services and clinical diagnostics to improve patient care. Clinical Data's molecular services division is among the largest independent providers of pharmacogenomics and metabolomics services globally and consolidates the operations of Genaissance Pharmaceuticals, Inc., Lark Technologies, Inc. and Icoria, Inc., each acquired during 2005. The division is utilizing pharmacogenomics to develop molecular diagnostics and more efficacious therapeutics by finding genetic markers to guide drug development and utilization. These services are marketed to the pharmaceutical, biotech, clinical, academic, government and agricultural marketplaces. 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., which are each focused on the small volume clinical diagnostics market worldwide. Vital Diagnostics' instrumentation business has a market focus on the physician's office, hospital and small-to-medium sized laboratory segments. With customers in approximately 100 countries, Vital Diagnostics has also 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 the expected timing of clinical trials studying vilazodone, the potential clinical benefits of vilazodone, and the growth and development of Clinical Data's business and market opportunities. 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 vilazodone will advance further in the clinical trials process; whether future clinical trials will warrant continued product development; whether and when, if at all, vilazodone will receive final approval from the U.S. Food and Drug Administration or equivalent regulatory agencies, and for which indications; the extent to which genetic markers (haplotypes) are predictive of clinical outcomes and drug efficacy and safety; whether vilazodone will be successfully marketed; 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.

(1)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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Comment:Clinical Data Initiates Pivotal Phase III Trial for Novel Antidepressant; First Ever Pharmacogenomic Screening Tool for Antidepressant to be Developed Concurrently.
Publication:Business Wire
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Date:Jan 26, 2006
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