Celladon Completes Enrollment of CUPID 2 Trial for Advanced Heart Failure
Celladon Corporation (Nasdaq:CLDN), a clinical-stage biotechnology company focused on developing novel therapies based of SERCA enzymes,announced it has completed enrollment and randomized 250 patients in the phase 2b trial titled "Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease," known as CUPID 2, which is evaluating the efficacy and safety of MYDICAR (AAV1/SERCA2a) in patients with NYHA class III/IV symptoms of systolic heart failure. CUPID 2 results are expected in April 2015.
“The CUPID 2 trial is a multinational, multicenter, double-blind, placebo-controlled, randomized trial of a single intracoronary infusion of high-dose MYDICAR (1 x 1013 DRP) versus placebo added to a maximal, optimized heart failure regimen. The primary objective is to determine the efficacy of MYDICAR in patients with ischemic or non-ischemic cardiomyopathy and advanced symptoms of heart failure by reducing the frequency and/or delaying heart failure-related hospitalizations compared to placebo-treated patients. Secondary objectives include assessment of terminal events, such as death, need for a ventricular assist device, or heart transplant. In addition, the safety of MYDICAR will be determined by assessing the incidence and severity of adverse events and changes in laboratory parameters.”
Company’s therapy MYDICAR is genetically-based enzyme replacement therapy that intents to restore Sarco/endoplasmic reticulum Ca2+-ATPase SERCA 2a. This enzyme is deficient in people with congestive heart failure.