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Clinical Data, Inc. Granted Orphan Drug Designation for PRX-8066 for Pulmonary Arterial Hypertension

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3.2 from 10 votes
Monday, November 01, 2010

NEWTON, Mass. -- Clinical Data, Inc. (NASDAQ: CLDA) today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for pulmonary arterial hypertension (PAH) to PRX-8066, the Company's selective serotonin 2B (5-HT2B) receptor antagonist.

The expression of 5-HT2B receptors is elevated selectively in the pulmonary vasculature of PAH patients, and these receptors mediate abnormal cell growth and proliferation (1). Analyses of results from a Phase II study of PRX-8066 in pulmonary hypertension associated with chronic obstructive pulmonary disease (COPD) demonstrated its capacity to reduce elevated pulmonary pressures. Based on these results and findings from animal models, the Company is developing plans for the continued clinical development of PRX-8066 for patients with PAH.

“Obtaining Orphan Drug Designation is an important first step in developing our clinical program for PRX-8066,” said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. “The scientific rationale and encouraging results of clinical studies of PRX-8066 in patients with pulmonary hypertension support further studies for this indication and potentially other disorders.”

Blocking the activity of the 5-HT2B receptor is predicted to alleviate symptoms and modify disease progression. PRX-8066 has demonstrated beneficial effects on pulmonary blood pressure in clinical studies and effects on vasodilatation and vascular remodeling of the pulmonary vasculature in animal models of disease (2).

Orphan Drug Designation is granted to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides developers with a seven-year period of U.S. marketing exclusivity upon marketing approval for the designated indication, as well as with tax credits for clinical research costs, the ability to apply annually for grant funding, clinical research trial design assistance and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

About PRX-8066

PRX-8066 (also referred to as “PRX-08066”) is a 5-HT2B receptor antagonist in Phase II development for patients with pulmonary arterial hypertension and potentially other disorders. A Phase II study in patients with COPD, conducted by a former sponsor of PRX-8066, demonstrated its potential to reduce elevated pulmonary pressures. PRX-8066 has been found to be well tolerated in clinical studies with diarrhea and nausea as the most common adverse events. It has also shown positive pharmacodynamic effects in animal models of pulmonary hypertension triggered by hypoxia (lack of oxygen). The Company is currently planning further clinical studies of PRX-8066 in patients with PAH.

About Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) is characterized by the elevation of pulmonary vascular pressures with progressive abnormal cell proliferation resulting in narrowing of vessels of the pulmonary artery system, ultimately leading to right-sided heart failure. Patients with PAH present with dyspnea (or shortness of breath) at rest and/or with exercise, reduced exercise capacity, and other signs and symptoms of right heart failure. According to the National Institutes of Health Registry on Primary Pulmonary Hypertension, the average survival time of untreated patients was 2.8 years from the time of diagnosis, with right heart failure as the cause of death.3 Consistent with the requirements for designation as an orphan disease, PAH is a rare disease with a prevalence in the United States of less than 200,000 people.

About Clinical Data, Inc.

Clinical Data develops first-in-class and best-in-category therapeutics. The Company is advancing its late-stage drug candidates for central nervous system disorders and cardiovascular diseases, to be followed by promising drug candidates in other major therapeutic areas. Clinical Data combines its drug development and biomarker expertise in an effort to develop products with enhanced efficacy and tolerability to improve patient health and reduce costs. To learn more, please visit the Company's website at www.clda.com.

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 obtain regulatory approval for, and successfully introduce, PRX-8066 and our other drug candidates; our ability to expand our long-term business opportunities; and all other statements regarding future performance. All 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 contained in this press release. These risks and uncertainties include, but are not limited to, whether PRX-8066 or any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, PRX-8066 or any of our other therapeutic products will receive final approval from the U.S. Food and Drug Administration and equivalent foreign regulatory agencies and for which indications; whether PRX-8066 or any of our other therapeutic products will be successfully marketed if approved; the strength of our intellectual property rights; competition from pharmaceutical, biotechnology and diagnostics companies; general economic conditions; 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 publish 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, 2010, Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2010, and Current Reports on Form 8-K filed from time to time by the Company.

1 Launay JM, et al. Function of the serotonin 5-hydroxytryptamine 2B receptor in pulmonary hypertension. Nat.Med. 2002 Oct;8(10):1129-35.

2 Porvasnik SL, et al. PRX-08066, a Novel 5-hydroxytryptamine Receptor 2B (5-HT2B) Receptor Antagonist, Reduces Monocrotaline-induced Pulmonary Arterial Hypertension and Right Ventricular Hypertrophy in Rats. J Pharm Exp Therap. 2010 Aug; 334(2): 364-372.

3 Rich S, et al. Primary pulmonary hypertension: A national prospective study. Ann Intern Med. 1987; 107(2): 216-223.

Clinical Data, Inc.
Theresa McNeely, 617-467-6673
Vice President
Corporate Communications
Source: Clinical Data, Inc.
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