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Dr. Craig McDonald to Provide Update in Late Breaking Oral Presentation
LOS ANGELES, Sept. 17, 2019 (GLOBE NEWSWIRE) -- Capricor Therapeutics (CAPR), a clinical-stage biotechnology company focused on the development of first-in-class biological therapeutics for the treatment of Duchenne muscular dystrophy (DMD) and other rare disorders, today announced that it will present results from the randomized, double-blind, Phase II HOPE-2 clinical trial of CAP-1002 in boys and young men with Duchenne muscular dystrophy (DMD) at the 24th International Congress of the World Muscle Society. The late breaking results will be presented in an oral session on October 5, 2019. The International Congress of the World Muscle Society will be held October 1 – 5, 2019 at Tivoli Gardens in Copenhagen, Denmark.
“I am delighted to present expanded interim results from the HOPE-2 clinical trial to the Congress of the World Muscle Society, as we are honored to be selected for one of the late breaking oral presentations in this prestigious conference,” said Craig McDonald, M.D., the national principal investigator for the HOPE-2 clinical trial and UC Davis professor and chair of its Department of Physical Medicine and Rehabilitation. “The selection for a late breaking podium presentation at this meeting from the many meritorious submissions reflects the excitement in the field for this clinical trial treating the later stage non-ambulant DMD patients. This is the first therapeutic in DMD to lead to meaningful functional improvements using the recently validated Performance of Upper Limb (PUL) Measure. The consistency of benefit across multiple endpoints with CAP-1002, a systemically administered cell-based therapy, gives us hope that this may be an important treatment option for these boys and young men.”
Recently, we announced positive top-line interim results from the HOPE-2 clinical trial, and we are looking forward to sharing additional data from this exciting trial at the World Muscle Society.” said Linda Marbán, Ph.D., Capricor’s president and chief executive officer. “There is a major unmet need for new therapies that address the consequences of DMD in the later stages of the disease. It is not well-recognized that over half of the DMD population is primarily non-ambulant. We continue to discuss the clinical development of CAP-1002 for DMD with the U.S. Food and Drug Administration (FDA) and look forward to sharing those updates as they become available.”
Dr. McDonald is a professor of pediatrics, professor and chair of the Department of Physical Medicine and Rehabilitation, director of Rehabilitation Services and director of the Neuromuscular Disease Clinics at UC Davis Health. He has served as principal investigator for more than 30 industry sponsored trials for DMD. He is the study chair for the Duchenne Natural History Study of the Cooperative International Neuromuscular Research Group, which is a consortium of medical and scientific investigators from academic and research centers who share the common goal of aiming to positively impact the lives of neuromuscular disease patients and their families by conducting well-controlled clinical studies.
In July, Capricor announced positive top-line results from its interim analysis in the HOPE-2 trial.
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.
CAP-1002 consists of allogeneic cardiosphere-derived cells (CDCs), a type of progenitor cell that has been shown in pre-clinical and clinical studies to exert potent immuno-modulatory activity and is being investigated for its potential to modify the immune system’s activity to encourage cellular regeneration. CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered to over 150 human subjects across several clinical trials.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (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 DMD. Capricor is also 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; 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, revenue projections; 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, 2018 as filed with the Securities and Exchange Commission on March 29, 2019, and as amended by its Amendment No. 1 to Annual Report on Form 10-K/A filed with the Securities and Exchange Commission on April 1, 2019, in its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2019, as filed with the Securities and Exchange Commission on August 8, 2019, and in its Registration Statement on Form S-3 as filed with the Securities and Exchange Commission on October 24, 2018, and as amended by its Amendment No. 1 to Form S-3 filed with the Securities and Exchange Commission on July 17, 2019, together with prospectus supplements thereto. 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