Heart Failure Clinical Trial
Official title:
A Phase 1/2 Study of the Safety and Preliminary Activity of MYDICAR® at a Dose of 2.5 x 10^13 DNase Resistant Particles (DRP) in Subjects With Advanced Heart Failure Divided Into 2 Phases: Phase 1 Open-label and Phase 2 Randomized, Double-blind, Placebo-controlled
The purpose of this trial is to characterize the safety profile and preliminary activity of high-dose MYDICAR® in persons with advanced heart failure when added to their maximal and optimized therapy.
Heart failure (HF) is a disabling chronic disease and the most frequent discharge diagnosis
for hospitalization among older adults.The American Heart Association (AHA) 2006 update on
heart disease reported that 5 million Americans are believed to have symptomatic HF, and
550,000 patients are newly diagnosed each year. The estimated direct and indirect cost of HF
in the United States (U.S.) for 2006 was ~$29.6 billion. Despite the significant resources
expended on the treatment of this disease, outcomes remain poor. The five-year survival for
individuals diagnosed with HF is less than 50%, and in end-stage HF, the one-year survival
may be as low as 25% regardless of medical therapy.
Recent studies suggest that the failing heart is not refractory to treatment, as was
previously believed. For example, the observation that a small percentage of subjects with
left ventricular assist devices can be permanently weaned from their device strongly
suggests that damaged hearts are capable of recovering lost function.
Celladon Corporation (Celladon) is investigating gene transfer as a method to restore
calcium ion (Ca++) cycling in HF patients. The gene therapy vehicle uses a recombinant
adeno-associated viral vector (AAV), which consists of an AAV serotype 1 capsid and contains
the human sarcoplasmic reticulum Ca++ ATPAse (SERCA2a) complementary DNA (cDNA) flanked by
inverted terminal repeats derived from AAV serotype 2 (AAV1/SERCA2a). MYDICAR® refers to
AAV1/SERCA2a drug product intended for administration by percutaneous delivery. Phase 1/2
clinical trials have demonstrated initial safety and evidence of improvement in clinical
outcomes at MYDICAR doses of up to 1 x 10^13 DNase-resistant particles (DRP). The trial
described here is designed to investigate the safety profile and preliminary activity of
MYDICAR at a dose of 2.5 x 10^13 DRP; this dose is 2.5-fold higher than previously
investigated doses.
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