Two Phase I studies of Stedivaze demonstrate safety in patients with asthma and COPD

Mar 30 2010

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 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 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. The Company is also actively enrolling patients in ASPECT 1, a Phase III trial designed to demonstrate the safety and effectiveness of Stedivaze.

“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”

"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.