Additionally, the 12-month CUPID data show that heart failure, which is a progressive disease, became stabilized in high dose MYDICAR-treated patients: heart failure symptoms, exercise tolerance, serum biomarkers and cardiac function essentially improved or remained the same while these parameters deteriorated substantially in patients treated with placebo and concurrent optimal drug and device therapy.
The safety profile from this study was very favorable, with no significant side-effects from MYDICAR therapy.
Roger Hajjar, M.D., Director, Cardiovascular Research Center, Mount Sinai School of Medicine, NY, and co-founder of Celladon said: "While conventional treatment modalities have reduced heart failure mortality in the last 20 years, there remains a critical need for new therapeutic approaches in patients with advanced heart failure. The successful and safe completion of the phase 2 CUPID trial may give patients with heart failure a new therapeutic option in the future."
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 less than or equal to 35 percent), and less than half the normal ability to transport and utilize oxygen during exercise testing (VO2max less than or equal to 20 mL/kg/min). The CUPID trial ClinicalTrials.gov Identifier is NCT00454818.
Primary outcome measures included safety, worsening of heart failure leading to hospitalization, fr
|SOURCE Celladon Corp.|
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