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Favorable ALLSTAR phase 1 safety, efficacy results.

LOS ANGELES, Calif., November 18, 2014 -- Capricor Therapeutics, Inc. (CAPR) said one-year results of the Phase 1 ALLSTAR (Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration) clinical trial indicate that intracoronary injection of allogeneic cardiosphere-derived stem cells (CAP-1002) to achieve myocardial regeneration in patients with left ventricular dysfunction who have had an anterior myocardial infarction appears to be safe, with no deaths, no acute myocarditis and no major adverse cardiac events.

The safety endpoints of the trial, including no acute myocarditis attributable to CAP-1002, no deaths due to ventricular tachycardia or ventricular fibrillation, no sudden death and no major adverse cardiac events, were achieved with no endpoint events in the 14 enrolled subjects at 1 month and at 12 months.

The results showed that none of the pre specified safety endpoints occurred. In addition, exploratory efficacy data in this Phase 1 trial have shown improvements in ejection fraction and reduction in scar size, most notably in the Phase 2 equivalent population.

This study prospectively enrolled 14 adults from 40 to 66 years old with a recent (within 28 to 90 days) or chronic (within 91 to 365 days) anterior myocardial infarction, left-ventricular dysfunction and an infarct size >15 percent of left-ventricular mass and infused them with CAP-1002 at a dose of either 12.5M or 25M using stop-flow intracoronary infusion.

At baseline, the participants had left ventricular function impairment with a mean ejection fraction of 42 percent with a range of 26.7 percent to 55.1 percent.

In addition, exploratory efficacy data in this Phase 1 trial have shown improvements in ejection fraction and reduction in scar size, most notably in those participants who would be included in the Phase 2 clinical study by virtue of dose and tissue type compatibility.

With respect to those participants, the data showed a relative reduction at one year of 15 percent of infarct scar size and a nearly 4 percent absolute improvement in ejection fraction. The company suggests that these data be interpreted with caution as the sample size was small and there was no contemporaneous control group.

The Phase 2 trial began enrollment in January 2014, and is expected to enroll approximately 300 patients who have had an anterior myocardial infarction within 30 days to one year prior to enrollment, left ventricular function and an infarct size >15 percent of left-ventricular mass.

The participants will be randomized to receive cither CAP-1002 or placebo in a 2:1 ratio favoring CAP-1002.

In addition, Phase 2 will aim to further establish the safety and determine the efficacy of this therapy in reducing the scar size and improving the ejection fraction in these subjects with moderate to large anterior myocardial infarction who arc at significant risk of deterioration into heart failure and early death.

CAP-1002, Capricor's lead product candidate, is a proprietary allogeneic adult stem cell therapy for the treatment of heart disease. The product is derived from donor heart tissue. The cells are expanded in the laboratory using a specialized process and then introduced directly into a patient's heart via infusion into a coronary artery using standard cardiac catheterization techniques.

CAP-1002 is not an approved product and is strictly for investigational purposes.

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Title Annotation:In The Clinic ...
Publication:Stem Cell Business News
Date:Dec 1, 2014
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