Clinical Data announces Stedivaze agonist data at ASNC2010 meeting

Sep 27 2010

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.

“We 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.”

"These 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," said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. "We 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."

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. - 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. - 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.