LOS ANGELES, May 31, 2017 /PRNewswire/ -- Capricor Therapeutics, Inc. (NASDAQ: CAPR) today announced that a formal meeting between Capricor and the U.S. Food and Drug Administration (FDA), at which Capricor plans to discuss potential product registration strategies for CAP-1002 (allogeneic cardiosphere-derived cells) in the Duchenne muscular dystrophy (DMD) indication, is scheduled to be held by telephone in the second half of June 2017. Capricor also announced today that it will deliver a presentation on its DMD therapeutic development program at the Parent Project Muscular Dystrophy (PPMD) 2017 Annual Connect Conference, to be held June 29 through July 2, 2017 in Chicago, Illinois.
Linda Marbán, Ph.D., president and CEO of Capricor, said, "We look forward to meeting with the FDA next month, both to provide detail on the six-month HOPE results as well as to discuss our plans to develop CAP-1002 for the treatment of Duchenne muscular dystrophy. In collaboration with a distinguished group of scientific and clinical leaders, we are currently designing a randomized, double-blind, placebo-controlled clinical trial of intravenous, repeat-dose CAP-1002 in DMD, in which we expect to begin patient enrollment in the latter half of this year, subject to regulatory approval."
Pat Furlong, Founding President and CEO of Parent Project Muscular Dystrophy, the largest nonprofit organization in the U.S. solely focused on Duchenne, said, "Each year nearly 500 families from around the world gather at our Connect Conference to learn the latest progress in the fight to end Duchenne. I'm delighted that the six-month results from the HOPE trial, which provide indication of CAP-1002's therapeutic potential in a population with advanced Duchenne, will be featured at this premier community event."
Capricor recently reported positive top-line six-month results from the randomized Phase I/II HOPE-Duchenne clinical trial of CAP-1002 (allogeneic cardiosphere-derived cells) in 25 boys and young men with DMD. Patients treated with CAP-1002 demonstrated statistically-significant improvement compared to usual care controls in certain measures of cardiac and upper limb function, and CAP-1002 was generally safe and well-tolerated over the initial six-month follow-up period.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company developing first-in-class biological therapies for cardiac and other medical conditions. Capricor's lead candidate, CAP-1002, is a cell-based candidate currently in clinical development for the treatment of Duchenne muscular dystrophy, myocardial infarction (heart attack), and heart failure. Capricor is exploring the potential of CAP-2003, a cell-free, exosome-based candidate, to treat a variety of disorders. For more information, visit www.capricor.com.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings, and any other statements about Capricor's management team's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "believes," "plans," "could," "anticipates," "expects," "estimates," "should," "target," "will," "would" and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor's business is set forth in Capricor's Annual Report on Form 10-K for the year ended December 31, 2016 as filed with the Securities and Exchange Commission on March 16, 2017, in its Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on September 28, 2015, together with prospectus supplements thereto, and in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, as filed with the Securities and Exchange Commission on May 15, 2017. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.
CAP-1002 is an Investigational New Drug and is not approved for any indications. Capricor's exosomes technology, including CAP-2003, has not yet been approved for clinical investigation.
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AJ Bergmann, Vice President of Finance
SOURCE Capricor Therapeutics, Inc.