Blog Coverage Capricor Announces Positive Results from Trial for the Treatment of Duchenne Muscular Dystrophy

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LONDON, UK / ACCESSWIRE / April 26, 2017 / Active Wall St. blog coverage looks at the headline from Capricor Therapeutics, Inc. (NASDAQ: CAPR) as the Company announced positive top-line results from a safety and exploratory efficacy analysis of six-month data from the randomized 12-month Phase I/II HOPE Clinical Trial of CAP-1002 (allogeneic cardiosphere-derived cells), an investigational candidate for the treatment of patients with Duchenne muscular dystrophy, or DMD. Register with us now for your free membership and blog access at:

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One of Capricor Therapeutics' competitors within the Biotechnology space, BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), announced on April 20, 2017, that Jean-Jacques Bienaimé, the Company's Chairman and CEO, will host a conference call and webcast on Thursday, May 04, at 4:30 p.m. ET to discuss Q1 2017 financial results and provide a general business update. AWS will be initiating a research report on BioMarin Pharma in the coming days.

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The Phase I/II HOPE Clinical Trial

The randomized HOPE (Halt cardiomyOPathy progression in Duchenne) clinical Trial was designed to evaluate the safety and exploratory efficacy of CAP-1002 in patients 12 years and older with DMD and who had cardiomyopathy, or heart disease, secondary to DMD as evidenced by scar in four or more left ventricular segments as detected by late gadolinium-enhancement MRI. Twenty-five patients were randomized to receive either a single dose of CAP-1002 or usual care. CAP-1002 was infused into each of the three main coronary arteries at a total dose of 75 million cells.

Capricor stated that in exploratory efficacy analyses, statistically-significant improvements in systolic thickening of the inferior wall of the heart, and in the function of the middle and distal upper limb according to a PUL responder analysis, were observed in patients treated with CAP-1002 as compared to usual care control patients. Additionally, differences observed in several other cardiac and skeletal muscle measures, including cardiac scar were consistent with a treatment effect.

CAP-1002 was generally safe and well-tolerated over the initial six-month follow-up period. Capricor has submitted a meeting request to the US Food and Drug Administration, or FDA, to discuss potential product registration strategies for CAP-1002 in the DMD indication.

"These initial positive clinical results build upon a large body of preclinical data which illustrate CAP-1002's potential to broadly improve the condition of those afflicted by DMD, as they show that cardiosphere-derived cells exert salutary effects on cardiac and skeletal muscle," said Linda Marbán, Ph.D., Capricor's President and Chief Executive Officer.

Going Forward

Capricor has submitted an FDA meeting request to discuss these results as well as next steps in its development of CAP-1002 for Duchenne muscular dystrophy, which includes plan to begin a clinical trial of intravenously-administered CAP-1002 in the latter half of this year. The Company believes the interim HOPE results may enable it to pursue one of the FDA's Expedited Programs for Serious Conditions, and that Capricor will apply for either or both of the Breakthrough Therapy and Regenerative Medicine Advanced Therapy (RMAT) designations for CAP-1002. The RMAT designation, intended to expedite the approval of safe and effective cell therapies, was created by the US Congress as part of the recently-enacted 21st Century Cures Act. Capricor expects to report top-line 12-month results from the HOPE-Duchenne Trial in Q4 2017.

Stock Performance

At the close of trading session on Tuesday, April 25, 2017, following the announcement, Capricor Therapeutics' stock price rose 4.53% to end the day at $3.23. A total volume of 3.24 million shares were exchanged during the session, which was above the 3-month average volume of 68.45 thousand shares. The Company's share price has surged 41.65% in the past three months and 21.43% on an YTD basis. The stock currently has a market cap of $72.45 million.

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