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Celladon Corporation Announces Publication of Advanced Heart Failure Clinical Trial Results With MYDICAR® Enzyme Replacement Therapy in the Journal Circulation
Date:6/27/2011

LA JOLLA, Calif., June 27, 2011 /PRNewswire/ -- Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announces that the data from its completed Phase 2 CUPID clinical study of MYDICAR® for the treatment of advanced heart failure is being published today online in Circulation, an American Heart Association journal.

"I am very encouraged that our approach of restoring a critical enzyme that is depleted in advanced heart failure may lead to new treatment options for those patients that continue to decline despite the best standard drug and device therapies," said Mariell Jessup, M.D., Professor of Medicine at the University of Pennsylvania's School of Medicine, who was the principal investigator and lead author of the study.  "The clinical deterioration seen in the placebo patients receiving ongoing optimal standard therapy emphasizes the tremendous unmet medical need in people with advanced heart failure. Based on these results we are encouraged that MYDICAR may one day fill this need."  

The previously announced top line results of 39 patients met its primary safety and efficacy endpoints at 6 months for high dose MYDICAR versus placebo.  Additionally, 12 months after 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 patient compared with 4.5 days per patient in the placebo group. This finding is especially noteworthy because heart failure i
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SOURCE Celladon Corp.
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