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CRSTI and Medical City Hospital Dallas Currently Recruiting For a Phase 2 Clinical Trial of MYDICAR(R) for Advanced Heart Failure
Date:12/15/2008

atients with heart failure and physicians interested in additional information on MYDICAR and the CUPID Trial, please visit: http://www.clinicaltrials.gov/ct/show/NCT00454818?order=1.

Patients may assess eligibility to participate in the CUPID trial and download a patient questionnaire and additional information to review with your physician by visiting http://www.celladon.net, under the "For Patients" tab.

Patients interested in enrolling in this clinical trial at the Cardiopulmonary Research Science and Technology Institute (CRSTI), Medical City Hospital may call 972-566-4083.

Study Results Presented at the American Heart Association Scientific Sessions

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 AAV vectors, which has been demonstrated in clinical studies of more than 500 patients. AAV vectors are the product of decades of research focused on the safety of gene transfer agents, and are derived from components of a non-replicating, non-pathogenic, commonly occurring human virus. AAV vectors do not integrate into the chromosome and are considered non-mutagenic. In addition, they have
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SOURCE The Cardiopulmonary Research Science and Technology Institute
Copyright©2008 PR Newswire.
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