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Wired News – FDA Cleared IND Application of Capricor to Conduct Phase-2 Trial of CAP-1002 for Duchenne Muscular Dystrophy

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LONDON, UK / ACCESSWIRE / December 01, 2017 / Active-Investors issued a free report on Capricor Therapeutics, Inc. (NASDAQ: CAPR), which is readily accessible upon registration at www.active-investors.com/registration-sg/?symbol=CAPR as the Company’s latest news hit the wire. On November 29, 2017, the Company announced the clearance of its Investigational New Drug (IND) application to conduct a new clinical trial of CAP-1002 in boys and young men in advanced stages of Duchenne muscular dystrophy (DMD) by the US Food and Drug Administration (FDA). Sign up now for our free research reports at:


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The Company plans to apply for the Regenerative Medicine Advanced Therapy (RMAT) Designation for CAP-1002 based on updated guidance recently issued by the FDA.

New Clinical Trial of CAP-1002

The randomized, double-blind, placebo-controlled new clinical trial of CAP-1002 will be called the HOPE-2 Trial, designed to evaluate the safety and efficacy of intravenous, repeat doses of CAP-1002 in boys and young men whose ability to walk has been seriously impaired by the loss of muscle function occurred as DMD progresses. The HOPE-2, likely to initiate in Q1 2018, is expected to enroll 84 patients and be conducted at 10-12 US sites.

The trial will test the potential benefit of CAP-1002 as a repeated therapy delivered intravenously, with the goal of providing long-term benefit in a format that is compatible with repeat dosing over time. The Company believes that if the primary endpoint is reached, the results of the HOPE-2 Trial could support the submission of a Biologics License Application (BLA) to obtain marketing approval of CAP-1002.

CAP-1002 One of the few Clinical Initiatives to Focus on Non-Ambulant Patients

Commenting on the clearance, Linda Marbán, Ph.D., President and CEO of Capricor, stated that the FDA's clearance of this IND upon its initial submission is a significant step forward in the development of CAP-1002. While there are many clinical initiatives in DMD, this is one of the very few to focus on non-ambulant patients.

Significant Improvements Were Reported in DMD Patients Treated with CAP-1002

On November 15, 2017, Capricor reported that boys and young men in advanced stages of DMD experienced significant and sustained improvements in cardiac structure and function as well as skeletal muscle function, following a single dose of intracoronary CAP-1002.

Capricor Planned to Initiate Patient Enrollment into HOPE-2 Trial

On October 25, 2017, Capricor, while presenting results from HOPE-1 clinical trial of CAP-1002, shared its plan to initiate patient enrollment into the HOPE-2 clinical trial of intravenous, repeat-dose CAP-1002 in boys and young men with DMD in Q1 2018.

What is Duchenne Muscular Dystrophy?

DMD is a genetic disorder characterized by progressive muscle degeneration and weakness. It is caused by an absence of dystrophin, a protein that helps keep muscle cells intact. Symptom onset is in early childhood, usually between ages 3 and 5, and leads to death, generally before the age of 30, most commonly from heart failure. The disease primarily affects boys, but in rare cases it can affect girls.

About CAP-1002

CAP-1002, Capricor’s lead investigational therapy, is an allogeneic product (manufactured from donor heart tissue and then stored until needed for use) consisting of allogeneic cardiosphere-derived cells. CAP-1002 has been shown to exert potent immunomodulatory activity and alters the immune system’s activity to encourage cellular regeneration.

About Capricor Therapeutics, Inc.

Founded in 1996, Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of first-in-class biological therapeutics for the treatment of rare disorders, including cardiac and other medical conditions. The Company is headquartered in Beverly Hills, California.

Stock Performance Snapshot

November 30, 2017 - At Thursday’s closing bell, Capricor Therapeutics’s stock dropped 8.29%, ending the trading session at $1.88.

Volume traded for the day: 853.12 thousand shares.

Stock performance in the last three-month period – up 84.31%; and past six-month period – up 127.88%

After yesterday’s close, Capricor Therapeutics’s market cap was at $48.33 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.8% at the end of the session.


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