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Clinical Data, Inc. Presents Data from Phase I Studies of Stedivazea" Demonstrating Safety and Tolerability in Patients with As

^{Published on 2010-09-24 08:56:00 - Market Wire}
 

PHILADELPHIA--([ BUSINESS WIRE ])--[ Clinical Data, Inc. ] (NASDAQ: [ CLDA ]), today presented data from Phase I studies of Stedivaze (apadenoson), which demonstrated overall safety and tolerability in patients with asthma and chronic obstructive pulmonary disease (COPD). [ Stedivaze ] is a potent and highly selective agonist of the adenosine A_2A receptor subtype in development as a pharmacologic stress agent for myocardial perfusion imaging (MPI). Currently available adenosine agonists must be used with caution or are contraindicated in patients with asthma and COPD. The findings, presented at the annual meeting of the American Society of Nuclear Cardiology (ASNC2010) and published in the Journal of Nuclear Cardiology, support the potential advantage of Stedivaze for use in these populations, which account for approximately 10 percent of the 7.6 million MPI tests performed annually. ¹

"A2A a" adenosine Receptor Reserve for Coronary Vasodilation"

aThese findings support the potential advantage of Stedivaze as a more selective adenosine agonist for use in patients with asthma and COPD, as well as in the broader MPI testing market,a said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. aWe are planning an expanded safety study of Stedivaze in patients with asthma and COPD, while continuing to evaluate the efficacy and potential for superior tolerability of Stedivaze in our ongoing Phase III ASPECT 1 trial.a

ASNC2010 Presentation Summaries:

A Randomized, Double-blind Placebo-controlled Study of the Safety of Apadenoson in Subjects with Mild or Moderate Asthma
Presenters: Amy Lankford, Ph.D and Carol Reed, M.D., PGxHealth, a division of Clinical Data, Inc.
Poster # 9.12, Friday September 24, 2010, 11:45 a.m. a" 1:15 p.m.

In this Phase I, placebo-controlled study, Stedivaze was administered to 49 patients with mild to moderate asthma as a single IV bolus, the same as utilized in the ongoing Phase III ASPECT 1 trial. Treatment with Stedivaze did not have any effects on pulmonary function and did not induce bronchoconstriction. In addition, Stedivaze treatment resulted in a low incidence of side effects that were transient and mild or moderate in severity. The most commonly reported treatment effects included palpitations, flushing, dizziness and tachycardia, all effects which are expected for this class of agents. Results of the trial support the tolerability of Stedivaze and continued study in patients with mild or moderate asthma.

A Randomized, Double-blind Placebo-controlled Study of the Safety of Apadenoson in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Presenters: Shannon Williams, Ph.D. and Carol Reed, M.D., PGxHealth, a division of Clinical Data, Inc.
Poster # 9.13, Friday September 24, 2010, 11:45 a.m. a" 1:15 p.m.

In this Phase I, placebo-controlled study, Stedivaze was administered to 50 patients with moderate to severe COPD as a single IV bolus, the same as utilized in the ongoing Phase III ASPECT 1 trial. Treatment with Stedivaze did not have any effects on pulmonary function and there appeared to be no association between severity of disease and the overall incidence or severity of treatment emergent adverse events. In addition, Stedivaze treatment resulted in a low incidence of side effects, all of which are expected for this class of agents, and included chest discomfort, shortness of breath, flushing, palpitations and headache. Results of the trial support the tolerability of Stedivaze and continued study in patients with moderate to severe COPD.

[ http://www.pgxhealth.com/mediainfo/publications.cfm ].

In addition to completing these Phase I studies, the Company is continuing to enroll patients in its ASPECT 1 trial of Stedivaze, a Phase III randomized, double blind, active control study initiated in November 2009. ASPECT 1 is designed to demonstrate both efficacy and the potential for improved tolerability for Stedivaze in patients undergoing SPECT MPI. ASPECT 2, a second Phase III trial similar in design to ASPECT 1, is expected to begin later this year or in early 2011.

About Stedivaze

[ Stedivaze ] (apadenoson) is a potent agonist of the adenosine A_2A receptor subtype and offers improved selectivity for this receptor overother subtypes (A₁ and A_2B). Phase II studies suggest that Stedivaze produces ample coronary artery vasodilation required for SPECT MPI testing and has a pharmacokinetic profile that will allow it to be administered as a fixed dose bolus injection. Because of its superior selectivity for the A_2A receptor subtype and its optimal pharmacokinetic profile, Stedivaze may offer improved tolerability over other adenosine receptor agonists currently marketed for use in pharmacologic stress MPI. The Phase III ASPECT 1 trial of Stedivaze, which began in November 2009, is designed to demonstrate both efficacy and the potential for improved tolerability of Stedivaze in patients undergoing SPECT MPI.

About Myocardial Perfusion Imaging

Myocardial perfusion imaging is used as a primary screen to identify the presence of coronary artery disease (CAD) as evidenced by detection of areas of poor blood flow in the heart that can be caused by the presence of plaques that can reduce or block the normal flow of blood to the heart. A pharmacologic stress agent is used to temporarily increase blood flow through normal coronary arteries in order to define areas of the heart that may be receiving reduced blood flow under rest and then stress conditions. The A_2A adenosine receptor is the receptor subtype responsible for coronary vasodilation, or the widening of blood vessels that increase the supply of blood to the heart muscle.²

The U.S. market for MPI testing is projected to be $800 million in 2011. Over 7.6 million MPI tests were performed in the U.S. in 2008 and approximately 3.5 million of these tests required the use of a pharmacological agent to generate maximum coronary blood flow in lieu of exercise.³ The market is expected to continue to grow due to an aging population, a rise in the number of patients unable to perform exercise during diagnostic procedures, and emerging imaging modalities that require the use of a vasodilator.

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 Stedivaze; 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. These risks and uncertainties include, but are not limited to, risks related to whether Stedivaze or any of our therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration and equivalent foreign regulatory agencies and for which indications; whether Stedivaze or any of our other therapeutic products will be successfully marketed if approved; 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 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 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 March 31, 2010, and Current Reports on Form 8-K filed from time to time by the Company.

¹Eliana Reyes, MD, et al. Adenosine myocardial perfusion scintigraphy in obstructive airway disease. Journal of Nuclear Cardiology, November/December 2007

²Shryock, J.C., Snowdy, S., Baraldi, P.G., et al. aA_2Aa" adenosine Receptor Reserve for Coronary Vasodilation,a Circulation, 1998, pp. 711-718.

³AMR Monthly Monitor SNM: Advanced Molecular Imaging and Therapy, September 15, 2008.