Celladon Announces Presentation of Clinical Data From First-in-Human MYDICAR(R) Trial for Advanced Heart Failure at American Heart Association Scientifi...(is a recombinant adeno-associated viral ...),Health

Date:11/9/2008

is a recombinant adeno-associated viral (rAAV) vector that transfers the SERCA2a gene into heart muscle cells. MYDICAR is delivered in a single dose directly to the heart muscle during a short outpatient procedure, performed in a standard cardiac catheterization laboratory via a small incision in the upper leg.

"These data demonstrate the safety of MYDICAR, and the improvements in cardiac function and overall condition observed in some patients further validate our target and approach," said Krisztina M. Zsebo, Ph.D., Chief Executive Officer of Celladon. "Given these early encouraging results, we are excited to have been given clearance to move into phase 2 of our study to continue to evaluate the ability of MYDICAR to improve heart function in more patients."

CUPID, which is funded by Celladon, is a Phase 1/2 trial. The Phase 1 portion reported today is an open-label, sequential dose escalation study. The Phase 2 portion is a randomized, double-blind, placebo-controlled, parallel-group, dose ranging trial that compares the use of MYDICAR at two or three dose levels with placebo. CUPID is expected to enroll 46 patients with advanced heart failure at 15 U.S. medical centers.

Study Results

Data from the Phase I in advanced heart failure was presented, and demonstrated that MYDICAR had an acceptable safety profile in these first nine patients, as determined by study investigators and an independent safety committee. In addition, improvements from baseline to six months across a number of parameters important in assessing heart failure status were observed, including symptomatic (5 patients), functional (4 patients), biomarker (2 patients) and left ventricular function/remodeling (6 patients). Of the nine patients treated, two with low levels of pre-existing antibodies to the AAV vector did not show improvement in these parameters.

The data are consistent with safety established for other rAAV vectors, which has been demonstrated in cl
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SOURCE Celladon Corporation Copyright©2008 PR Newswire. All rights reserved

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