In the additional two year follow up period of the CUPID 1 trial, the durability of reduced cardiovascular and terminal events previously observed in the MYDICAR high dose cohort at 12 months was maintained. The following recurrent cardiovascular and terminal events were tracked over the three years in all MYDICAR dose groups: myocardial infarction, worsening heart failure, heart failure-related hospitalization, left ventricular assist device (LVAD) placement, heart transplantation, and all-cause death. The risk of pre-specified recurrent cardiovascular events through full three years of follow up was reduced by 82% in the high dose group compared to the placebo group (p=0.048, where p-value is the statistical probability of a result due to chance alone).
In addition, the survival probability over time was higher for patients in all MYDICAR dose groups compared to the placebo group, especially in the high dose group. At three years post-administration, there were 13 deaths: six in the placebo group, three in the low-dose group, three in the mid-dose group and one in the high-dose group. Finally, persistence of the vector DNA as assessed by qPCR testing was demonstrated in three high dose MYDICAR patients in whom a biopsy was feasible, but not from patients in the placebo or lower dose groups. No safety concerns were noted during the three year follow-up period.
About the CUPID 1 Trial
Phase 2a of the CUPID 1 trial was a clinical trial using Celladon's lead product candidate MYDICAR in patients with advanced heart failure. In this 39-patient tria
|SOURCE Celladon Corporation|
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