Phase 2 study of Revascor for the treatment of congestive heart failure (CHF)
Cephalon and Mesoblast Limited announced positive interim results from its ongoing multi-center Phase 2 trial of Revascor for patients with congestive heart failure (CHF). This trial is an ongoing, randomized, placebo-controlled, multi-center trial in 60 patients with moderate-severe congestive heart failure. Analyses of time-dependent hard efficacy endpoints showed that a single injection of Revascor significantly reduced the number of patients who developed any severe adverse cardiac events over the follow-up period from 93.3% in the control group to 44.4% in the treated patients (p=0.001). Revascor also significantly reduced the number of patients who developed any major adverse cardiac events (MACE, defined as the composite of cardiac death, heart attack, or coronary revascularization procedures) from 40% to 6.7% (p=0.005). A single injection of Revascor reduced the overall monthly event rate of a MACE by 84% compared with controls (p=0.01), and every dose tested demonstrated a similar protective effect.
Revascor is an allogeneic cell therapy product being developed to reverse CHF by rebuilding both blood vessels and heart muscle. It is delivered to damaged areas of the heart by a minimally invasive cardiac catheterization procedure performed under local anesthesia while the patient is awake.
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