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.
"We believe the clear safety and efficacy sustained in patients over a 12-month period strongly support the continued development of MYDICAR for a Phase 3 study and commercialization," said Krisztina Zsebo, Ph.D., President and CEO 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, f
|SOURCE Celladon Corp.|
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