News | September 24, 2014

Capricor Presents Efficacy Results of Stem Cells to Achieve Myocardial Regeneration

From ALLSTAR Phase I clinical trial at TCT 2014

Capricor ALLSTAR Phase I Clinical Trial TCT 2014 Stem Cells Myocardial Regenerat

September 24, 2014 — Capricor Therapeutics Inc. presented an abstract entitled "ALLogeneic Heart STem Cells To Achieve Myocardial Regeneration (ALLSTAR): The Six Month Phase I Safety Results" with an oral presentation by Raj R. Makker, M.D., of Cedars-Sinai Medical Center, at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) conference Sept. 16.

The first-in-human Phase I ALLSTAR trial was designed to test the safety and feasibility of intracoronary infusion of allogeneic cardiosphere-derived cells (CAP-1002) in patients with a previous anterior myocardial infarction (MI), within the prior 12 months, with infarct (scar) size 15 percent by magnetic resonance imaging (MRI).

MRI data collected on the patients in the open-label dose-escalation study revealed that those patients who would be included in the Phase II clinical study, by virtue of dose and tissue type compatibility, show an increase in ejection fraction by 5.2 percent and a relative reduction in scar size of 20.7 percent at 12-month follow-up. The presentation highlighted that intracoronary infusion of allogeneic cardiosphere-derived cells (CAP-1002) appears to be safe and on track for demonstrating efficacy. Ongoing safety follow-up of Phase I subjects continues to reflect a favorable profile. The presentation of the available 12-month data will be held at a meeting of the American Heart Assn., Nov. 15-19, 2014 in Chicago. Phase I was funded in large part by a grant received from the NIH. Phase II, which is currently enrolling, is funded with the support of the California Institute for Regenerative Medicine. The overall primary efficacy endpoint of Phase II will be scar size reduction at one year.

"We are pleased to have been selected to present results of our Phase I ALLSTAR trial at TCT," said Capricor CEO, Linda Marban, Ph.D. "Our Phase I study indicates we are on track with both safety and feasibility, and favorable efficacy data continues to be compiled. We are also grateful to all the clinical investigators at Cedars-Sinai Heart Institute, The Minneapolis Heart Institute and The Scripps Research Institute, who continue to conduct our innovative clinical trials."

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