Celladon, Momentum Research Complete Enrollment For Mydicar Phase 2 Study

Celladon and Momentum Research have reported the completion of enrollment of the phase 2 double-blind portion of the Calcium Up-regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID) trial. Mydicar is an enzyme-replacement therapy intended to restore levels of SERCA2a in heart.

The randomized, double-blind, placebo-controlled study is designed to examine the effect of Mydicar (AAV1/SERCA2a) in the treatment of severe heart failure.

The CUPID trial enrolled 37 patients with severe forms of ischemic and dilated cardiomyopathies who had New York Heart Association Class III or IV heart failure.

Patients were treated with 1 of 3 doses of Mydicar or placebo via a single intracoronary infusion and will be followed for 12 months. Effects of treatment will be assessed by changes in how the heart contracts, a blood test of an important marker of heart failure called NT-proBNP, symptoms of heart failure and ability to exercise.

Krisztina Zsebo, president and CEO, said: “Strong interest in Mydicar from investigators and patients emphasizes the substantial unmet medical need in these very sick patients with few other viable options. Patients will be observed for 6 months, and we expect Interim data results to be available mid-2010.

“We remain encouraged by the meaningful improvements in cardiac function and overall condition of patients; findings that we believe demonstrate the return toward normal intracellular calcium cycling and contractility in some of the heart muscle cells.

“In addition, we have adequate Mydicar product manufactured to complete phase 3 and recently acquired an exclusive license to utilize Adeno-Associated Viral (AAV) vector technology in heart failure. This, combined with our extensive preclinical and clinical investigation of gene-based therapy for heart failure, bodes well for commercial product development of Mydicar and is important to potential strategic partners.”