Capricor Therapeutics Announces the First Patient with Duchenne-Related Cardiomyopathy Treated with CAP-1002 in the HOPE-Duchenne Phase I/II Clinical Trial

Capricor Therapeutics announced continuing enrollment of, and the treatment of the first patient with Duchenne-related cardiomyopathy with CAP-1002 in the HOPE-Duchenne Phase I/II clinical trial. This is an exciting next step in the  progress of CAP-1002, an allogeneic, cardiosphere-derived stem cell (CDC) therapy.


As you may recall, PPMD hosted a webinar with Capricor last month. Click below to watch the webinar, learn more about the trial, and read today’s full press release.

Watch PPMD's Webinar with Capricor

Read the Press Release from Capricor

Capricor Therapeutics Announces the First Patient with Duchenne Muscular Dystrophy-Related Cardiomyopathy Treated with CAP-1002 in the HOPE-Duchenne Phase I/II Clinical Trial


LOS ANGELES
Feb. 22, 2016 /PRNewswire/ -- Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company focused on the discovery, development and commercialization of first-in-class therapeutics, today announced continuing enrollment of, and the treatment of the first patient with Duchenne Muscular Dystrophy (DMD)-related cardiomyopathy with CAP-1002 in the HOPE-Duchenne Phase I/II clinical trial (Halt cardiomyOPathy progrEssion in Duchenne). CAP-1002 is Capricor's allogeneic, cardiosphere-derived stem cell (CDC) therapy. The patient was treated at the Cincinnati Children's Hospital Medical Center under the direction of Dr. John Jefferies, the national principal investigator for the HOPE-Duchenne trial. Enrollment is now ongoing at Cincinnati Children's Hospital Medical Center inCincinnati, Ohio and at Cedars-Sinai Heart Institute in Los Angeles, California.

The HOPE-Duchenne trial is designed to enroll 24 patients in a randomized, multi-center study evaluating the safety and efficacy of CAP-1002. Patients randomized to receive the cells will receive CAP-1002 in all three coronary arteries which will enable delivery extensively across the myocardium. Improvement in cardiac function was recently reported using this approach in Capricor's DYNAMIC trial for adult patients with Class III Heart Failure. Cardiomyopathy is currently the leading cause of death in patients with DMD now that other treatments are available to mitigate other aspects of the disease process.

"DMD is a genetic disorder characterized by progressive muscle deterioration. Patients with DMD also develop cardiopulmonary dysfunction in their teen years with death often occurring in their twenties," said John L. Jefferies, M.D., MPH, FAAP, FACC, Professor, Pediatric Cardiology and Adult Cardiovascular Diseases, University of Cincinnati College of Medicine, and Director, Advanced Heart Failure and Cardiomyopathy, Cincinnati Children's Hospital Medical Center. "Based on Capricor's prior encouraging clinical experience with CDC cell therapy in adults who have either suffered a heart attack or have heart failure, supplemented by the positive data in the mouse pre-clinical model of DMD (mdx), we are pleased to be able to begin the HOPE trial in boys and young men with DMD. Scarring is the hallmark of DMD cardiomyopathy and as the patients get older, the scar quantity expands and cardiac function then deteriorates. CDCs have been shown clinically in both the CADUCEUS and ALLSTAR Phase I clinical trials to reduce scar in the heart which might also benefit boys with DMD cardiomyopathy. We are happy to report that our first patient in the trial tolerated the CAP-1002 infusion procedure extremely well."

"We are thrilled to have initiated the HOPE-Duchenne clinical trial," said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. "CAP-1002 is to our knowledge the only clinical stage therapy intended to reduce fibrosis and scar in hearts affected by DMD. One of our goals with our CDCs is to target orphan diseases with cardiac implications, and DMD cardiomyopathy is our first target along these lines. We are hopeful that CAP-1002 may be a big step forward as a treatment option for DMD cardiomyopathy which at present is a progressive disease with poor therapeutic options."

For more information, please visit: http://capricor.com/hope/ or ClinicalTrials.gov (NCT02485938).

View the full press release.

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