SAN DIEGO, Aug. 29, 2012 -- Celladon Corporation, a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announced today that it has dosed the first patient in a Phase 2b clinical trial of MYDICAR, Celladon's first in class therapeutic for the treatment of advanced heart failure (HF).
Chronic HF is a leading cause of hospitalization and resulted in direct and indirect costs of $39.2 billion to the U.S. healthcare system in 2010. Nearly 6 million people in the U.S. have HF and at least 670,000 new cases are diagnosed yearly. Heart failure leads to an estimated 280,000 deaths annually. There is no cure.
The Phase 2b study titled "Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease" ("CUPID Phase 2b Trial") is a multinational, multicenter, double-blind, placebo-controlled, randomized study of a single intracoronary administration of 1 x 1013 DRP MYDICAR versus placebo added to an optimal HF regimen.
The primary objective is to determine the efficacy of MYDICAR in patients with ischemic or dilated cardiomyopathy and NYHA class III/IV symptoms of HF by reducing the frequency and/or delaying HF-related hospitalizations compared to placebo-treated patients. Secondary objectives will include assessment of the safety of MYDICAR by determining the incidence and severity of adverse events and changes in laboratory parameters. The trial will enroll approximately 200 patients in up to 50 international sites. Results are anticipated in the first half of 2015.
The Chairman of the Executive Clinical Steering Committee of the CUPID Phase 2b Trial is Barry H. Greenberg M.D., FACC, Director, Advanced Heart Failure Treatment Program; Professor of Medicine, University of California, San Diego. Dr. Greenberg stated, "We are enthusiastically looking forward to evaluating MYDICAR in the CUPID Phase 2b Trial for advanced heart failure. There is a major unmet need to provide safe and effective therapies for patients with advanced heart failure such as the ones who we will be studying in this trial."
"With the encouraging results from the preceding CUPID Phase 2 trial and the timely dosing of the first patient in this Phase 2b trial, we are firmly on track with our plan to develop a novel, safe, and effective therapy for patients with advanced heart failure," said Krisztina Zsebo Ph.D., President and CEO of Celladon Corp.
The first patient was dosed at Sharp Memorial Hospital in San Diego, CA by Brian Jaski, M.D., FACC, and Scientific Director of Research at the San Diego Cardiac Center. "We are grateful to be able to collaborate with Celladon for new innovative therapies for patients with serious heart failure. Heart failure is an increasing medical problem with no major breakthrough in medication therapy in over twenty years. Thus, there exists a large unmet need to help these patients." noted Dr. Jaski.
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