Clinical Data, Inc. Initiates Phase III Trial Of Stedivaze For Cardiac Stress Testing

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials;  Heart Disease
Article Date: 20 Nov 2009 - 1:00 PST

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Clinical Data, Inc. (NASDAQ: CLDA) announced that it has enrolled the first patient in its initial Phase III trial of Stedivaze™, a potential best-in-class vasodilator for use in cardiac stress testing. The study will evaluate the safety and efficacy of Stedivaze (apadenoson) for use as a pharmacologic stress agent in myocardial perfusion imaging (MPI), a method for detecting defects in the blood supply to the heart. The Phase III trial will also compare the tolerability of Stedivaze to adenosine, a standard pharmacologic stress agent used in MPI scans.

"The superior selectivity and pharmacokinetic profile of Stedivaze support its potential for improved tolerability compared to adenosine, as seen in Phase II studies," said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. "Our Phase III trial is designed to demonstrate that these attributes, combined with a convenient, fixed, single-dose bolus administration, may offer the best-in-class pharmacologic agent for use in cardiac stress testing."

The Phase III ASPECT Trial (Apadenoson Single Photo Emission Computed Tomography) is a randomized, double blind, active control study designed to determine whether Stedivaze is as effective as adenosine when used as a pharmacologic stress agent in SPECT MPI studies. Approximately 750 patients will be enrolled over an 18 to 24 month period at investigative sites in the U.S. Patients in the study will first undergo a clinically indicated SPECT MPI and then be randomized to receive a second SPECT MPI using either adenosine or Stedivaze. The incidence and severity of commonly reported side effects, such as shortness of breath, chest pain, dizziness, and headache, will also be evaluated to determine whether Stedivaze exhibits improved tolerability compared to adenosine.

About Stedivaze

Stedivaze (apadenoson) is a potent agonist of the adenosine A2A receptor subtype and offers improved selectivity over other adenosine receptor subtypes (A1 and A2B). Phase II studies suggest that Stedivaze produces ample coronary vasodilatory activity needed for cardiac stress MPI and has a pharmacokinetic profile that will allow it to be administered as a fixed dose bolus injection. Because of its improved 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. Stedivaze is in Phase III clinical development for use as a pharmacologic agent for myocardial perfusion imaging with the goals of demonstrating equal efficacy and improved tolerability compared to adenosine.

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 formation of plaques that block the normal flow of blood to the heart. A pharmacologic stress agent is used to increase blood flow through coronary arteries temporarily during stress testing in order to more strikingly define areas of the heart that receive poor blood flow. The A2A adenosine receptor is the receptor subtype responsible for coronary vasodilation, or the widening of blood vessels.1

The U.S market for MPI testing is projected to be $800 million. Over 7.6 million MPI tests were performed in the United States 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.2 The market is expected to continue to grow due to an increasing 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.

Source
Clinical Data, Inc.