CLDA news, PM
March 30, 2010 07:09 AM Eastern Daylight Time
Clinical Data, Inc. Reports Results of Phase I Studies of Stedivaze™ Demonstrating Safety and Tolerability in Patients with Asthma and COPD
Enrollment continues in Phase III ASPECT trial of Stedivaze
NEWTON, Mass.--(BUSINESS WIRE)--Clinical Data, Inc. (NASDAQ: CLDA), today announced results from two Phase I studies of Stedivaze™ (apadenoson), which demonstrated that Stedivaze was safe and well tolerated in patients with asthma and chronic obstructive pulmonary disease (COPD). Stedivaze is a potent and highly selective agonist of the adenosine A2A 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 high selectivity of Stedivaze offers a potential advantage for the safe use in this population, accounting for approximately 10 percent of the 7.6M MPI tests performed annually.1 The Company is also actively enrolling patients in ASPECT 1, a Phase III trial designed to demonstrate the safety and effectiveness of Stedivaze.
“A2A – adenosine Receptor Reserve for Coronary Vasodilation”
“The positive results from our preliminary studies in asthmatics and COPD patients are encouraging and represent a milestone toward our goal of developing a coronary vasodilator that is both safe and well tolerated in these populations,” said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. “We intend to expand these findings by initiating further safety studies 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 program.”
In both of these placebo-controlled studies, Stedivaze was administered as a single IV bolus, at the same dose utilized in the ASPECT 1 trial. In 49 patients with mild to moderate asthma and 50 patients with moderate to severe COPD, Stedivaze had no effects on pulmonary function tests. Adverse events overall were similar in both incidence and severity to the adverse event profile seen in previous studies of Stedivaze in patients without lung disease, and continue to support its potential for improved tolerability. Most frequently observed adverse events, common to this class of agents, included palpitations, flushing, chest discomfort and shortness of breath. Results of both of these trials support the continued study of Stedivaze in patients with asthma and COPD.
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, which 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 in the second half 2010.
About Stedivaze
Stedivaze (apadenoson) is a potent agonist of the adenosine A2A receptor subtype and offers improved selectivity for this receptor over other subtypes (A1 and A2B). 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 A2A 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.
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 A2A adenosine receptor is the receptor subtype responsible for coronary vasodilation, or the widening of blood vessels that supply 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, 2009, Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2009, 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. “A2A – adenosine Receptor Reserve for Coronary Vasodilation,” Circulation, 1998, pp. 711-718.
3AMR Monthly Monitor SNM: Advanced Molecular Imaging and Therapy, September 15, 2008.
