CRSTI and Medical City Hospital Dallas Currently Recruiting For a Phase 2 Clinical Trial of MYDICAR(R) for Advanced Hea...( DALLAS Dec. 15 /- The Cardiopulmonary...),Health

DALLAS, Dec. 15 /PRNewswire/ -- The Cardiopulmonary Research Science and Technology Institute (CRSTI), and Medical City Hospital, are currently enrolling patients for a Phase 2 clinical trial for advanced heart failure, "Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease" (CUPID Trial) for which the initial data were reported recently at the American Heart Association Scientific Sessions 2008. The study is evaluating MYDICAR(R), a genetically-targeted enzyme replacement therapy for advanced heart failure.

"The CUPID trial is designed to rescue a failing heart by replacing an enzyme known to play a critical role in normal cardiac muscle cell activity. Our goal is not only to improve the symptoms of heart failure, but restore physiologic function and reverse the severity of the disease," said Eric J. Eichhorn, MD, FACC, an interventional cardiologist with The Dallas Heart Group who works with Cardiopulmonary Research Science and Technology Institute, and is the principal investigator on the study at Medical City Dallas. "The recent data reported from the study demonstrate the safety of MYDICAR, and improvements in cardiac function and overall condition observed in some patients further validate our target and approach. Given these early encouraging results, we have begun enrollment of phase 2 clinical testing to evaluate the ability of MYDICAR to improve heart function in more patients."

The Phase 2 portion is a randomized, double-blind, placebo-controlled, parallel-group, dose ranging trial that compares the use of MYDICAR at two or three dose levels with placebo. CUPID is expected to enroll 46 patients with advanced heart failure at 15 U.S. medical centers. MYDICAR is delivered in a single dose directly to the heart muscle during a short outpatient procedure, performed in a standard cardiac catheterization laboratory via a small incision in the upper leg.

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