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Celladon Corporation Announces MYDICAR® Enzyme Replacement Therapy for Advanced Heart Failure Provides Sustained Clinical Improvements in Patients for 12 Months Compared with Placebo
Date:11/15/2010

CHICAGO, Nov. 15, 2010 /PRNewswire/ -- Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, today announced that 12-month data from its Phase 2 CUPID clinical trial of MYDICAR® demonstrated significant improvements in clinical outcomes and key disease markers in advanced heart failure patients treated with the genetically-targeted enzyme replacement therapy.

"Physicians and patients have long believed that a failing heart cannot be repaired, but the CUPID trial with MYDICAR adds support to other recent studies suggesting that the deterioration of heart function can indeed be slowed down, resulting in reduced hospitalizations and other cardiovascular events," said Donna Mancini, M.D., medical director of cardiac transplantation at NewYork-Presbyterian Hospital/Columbia University Medical Center and professor of medicine at Columbia University College of Physicians and Surgeons, who presented the study's one-year results during the American Heart Association Scientific Sessions 2010. "I am very encouraged that our approach of restoring a critical enzyme that is depleted in such advanced patients will enhance our understanding of the human heart."

The study of 39 patients met its primary safety and efficacy endpoints at 6 months for high dose MYDICAR versus placebo.  Additionally, after 12 months of receiving a single infusion of MYDICAR, patients treated with the highest dose versus placebo had an 88 percent risk reduction (Hazard Ratio = 0.12, P=0.003), of major cardiovascular events such as:

  • Death
  • Need for left ventricular assist device (LVAD) or cardiac transplant
  • Episodes of worsening of heart failure
  • Number of heart failure-related hospitalizations

The mean duration of hospitalization in the MYDICAR high dose group during the 12-month period was 0.4 days per pat
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SOURCE Celladon Corp.
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