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Celladon Corporation Announces MYDICAR® Enzyme Replacement Therapy for Advanced Heart Failure Provides Sustained Reduction in Clinical Events in Patients for 18 Months Compared with Placebo
Date:5/23/2011

th period strongly support the continued development of MYDICAR for a Phase 3 study and commercialization," said Roger Hajjar, M.D., Director, Cardiovascular Research Center, Mount Sinai School of Medicine, NY, and  co-founder of Celladon. "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 can fill this need."  

The CUPID Trial

The CUPID trial (Calcium Up-regulation by Percutaneous administration of gene therapy In cardiac Disease) is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of MYDICAR®, a genetically targeted enzyme replacement therapy for advanced heart failure. Enrolled patients had severe forms of the disease defined by New York Heart Association Class III or IV heart failure, significantly impaired pumping function of their hearts (ejection fraction ≤ 35 percent), and less than half the normal ability to transport and utilize oxygen during exercise testing (VO2max ≤20 mL/kg/min). The CUPID trial ClinicalTrials.gov Identifier is NCT00454818.

Primary outcome measures included safety, worsening of heart failure leading to hospitalization, frequency of and time to cardiac transplantation or LVAD implantation, changes in patients' ability to exercise, echocardiographic assessments, a blood test for NT-proBNP, and symptoms of heart failure.

About MYDICAR®

MYDICAR® is a genetically targeted enzyme replacement therapy intended to restore levels of SERCA2a, a regulator of calcium cycling and contractility. SERCA2a levels decline in all forms of late-stage heart failure resulting in deficient heart function. With MYDICAR®, the SERCA2a gene is delivered using a recombinant adeno-associated virus (AAV) as the vec
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SOURCE Celladon Corporation
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