Capricor to Give Update on HOPE-2 Clinical Trial for CAP-1002 at International Conference on Duchenne Muscular Dystrophy
Company to Launch Clinical Trial in March
LOS ANGELES, Feb. 12, 2018 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ:CAPR) will provide an update on HOPE-2, its trial for CAP-1002, the company’s lead investigational therapy for the treatment of Duchenne muscular dystrophy, at the 16th International Conference on Duchenne and Becker Muscular Dystrophy taking place in Rome this Friday through Sunday.
The three-day conference brings together scientists, physicians, companies, patients and their families to discuss the latest developments in Duchenne and Becker muscular dystrophy. Linda Marbán, Ph.D., Capricor president and chief executive officer, will provide a presentation on Sunday on HOPE-2, a randomized, double-blind, placebo-controlled clinical trial anticipated to begin enrolling participants in March.
“Our previous clinical trial, the HOPE-Duchenne Trial, found significant and sustained improvements in skeletal muscle function and cardiac structure following a single dose of intracoronary CAP-1002,” said Dr. Marbán. “The HOPE-2 Trial will test the potential benefit of CAP-1002 as a multi-dose therapy delivered intravenously – in patients in advanced stages of Duchenne muscular dystrophy.”
HOPE-2 will enroll approximately 84 boys and young men whose ability to walk has been seriously impaired by the loss of muscle function that occurs as Duchenne muscular dystrophy progresses. Capricor believes that if the primary endpoint is reached, the HOPE-2 Trial could serve as a potential registration trial.
For more information about HOPE-2, please visit: https://www.clinicaltrials.gov/ct2/show/study/NCT03406780?term=hope&cond=Duchenne+Muscular+Dystrophy&rank=2
About Duchenne Muscular Dystrophy
Duchenne muscular dystrophy is a devastating genetic disorder that causes muscle degeneration and leads to death, generally before the age of 30, most commonly from heart failure. It occurs in one in every 3,600 live male births across all races, cultures and countries. Duchenne muscular dystrophy afflicts approximately 200,000 boys and young men around the world. Treatment options are limited, and there is no cure.
About CAP-1002
CAP-1002 consists of allogeneic cardiosphere-derived cells, or CDCs, a unique population of cells that contains cardiac progenitor cells. CAP-1002 has been shown to exert potent immunomodulatory activity and stimulate cellular regeneration. CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered to approximately 140 human subjects across several clinical trials.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ:CAPR) 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. Capricor’s lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy. Capricor has also established itself as one of the leading companies investigating the field of extracellular vesicles and 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. The HOPE-Duchenne trial was funded in part by the California Institute for Regenerative Medicine.
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; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; 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 the prospectus included therein and prospectus supplements thereto, and in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, as filed with the Securities and Exchange Commission on November 14, 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. CAP-2003 has not yet been approved for clinical investigation.
For more information, please contact: AJ Bergmann, Chief Financial Officer +1-310-358-3200 abergmann@capricor.com
Released February 12, 2018