Biopharmaceutical company Cephalon Inc. and Mesoblast Limited (ASX: MSB), a leading global developer and manufacturer of biologic products, today announced positive interim results from Mesoblast’s ongoing multi-center phase 2 trial of its “off-the-shelf” proprietary adult stem cell product Revascor™ for patients with congestive heart failure.
Revascor is an allogeneic cell therapy product designed to reverse congestive heart failure. The product is administered by a minimally invasive cardiac catheterization procedure to damaged areas of the heart; the procedure is performed under local anesthesia while the patient is awake.
According to the phase 2 trial results, patients who received a single injection of Revascor have had less cardiac events, deaths and hospitalizations during the follow-up period to date than control patients.
Mesoblast is evaluating the safety and efficacy of Revascor in a randomized, placebo-controlled phase 2 trial in 60 patients with moderate-severe congestive heart failure. The companies reported that there have been no cell-related adverse events in any of the 45 patients treated with Revascor demonstrating that all three doses of the cell therapy product are safe over both the short and medium term.
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 percent in the control group to 44.4 percent in the treated patients;
• 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 percent to 6.7 percent;
• reduced the overall monthly event rate of a MACE by 84 percent compared with controls, and every dose tested demonstrated a similar protective effect.
Death from cardiac causes was reduced from 13.3 percent to 0 percent over this period and the overall monthly rate of cardiac-related hospitalizations was reduced by 48 percent.
“We are very pleased with these interim results that show for the first time that our proprietary technology can impact both quality of life and survival. If these long-term beneficial outcomes from a single dose of our adult stem cells are sustained they will translate into significant improvements to the quality of life and longevity of patients who are struggling with debilitating congestive heart failure,” Mesoblast CEO Professor Silviu Itescu stated in the press release.
Cephalon, CEO J. Kevin Buchi, said the results reflect Cephalon’s support and strategic investment in Mesoblast’s innovative adult stem cell technology platform. Buchi said the company will move forward with the clinical development of Revascor for the treatment of congestive heart failure toward a phase 3/pivotal trial.
For more information visit www.cephalon.com or www.mesoblast.com
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