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The Journal of Cardiac Failure Publishes Results From Celladon Corporation's First-in-Human Phase 1/2 Clinical Trial in Advanced Heart Failure
Date:4/8/2009

nd 2 at 12 months of follow-up and Cohort 3 at 6 months of follow-up. A total of 9 patients with NYHA Class III/IV Heart Failure received a single intracoronary infusion of MYDICAR. The overall review of study safety assessments to date has been unremarkable. No consistent clinically meaningful changes in blood pressure, heart rate, or body temperature were observed. No trends or significant changes have been noted in blood chemistries, electrolytes, or liver and kidney function tests. No clinically significant changes or trends were noted in any components of the electrocardiogram including intervals, rhythm, or QRS morphology. Several of these treated patients demonstrated improvements from baseline to month 6 across efficacy/biological parameters, including symptomatic (5 patients), functional (4 patients), biomarker (2 patients) and left ventricular function/remodeling (5 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.

"This peer reviewed publication of our results further validates our target and approach and we are excited to continue to evaluate the ability of MYDICAR to improve heart function in more patients in the Phase 2 portion of the study," said Krisztina M. Zsebo, Ph.D., Chief Executive Officer of Celladon.

The CUPID study is currently enrolling patients with advanced heart failure at 15 medical centers across the United States. MYDICAR is delivered in a single dose directly to the heart muscle during a short outpatient procedure, performed in a standard cardiac catheterization laboratory by inserting a catheter (thin flexible tube) through a peripheral blood vessel in the upper leg under x-ray guidance.

Patients with heart failure may assess eligibility to participate in the CUPID trial and download a patient questionnaire and additional information on MYDICAR to review with your physician by v
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SOURCE Celladon Corporation
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