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-To Provide Clinical Development Update on CAP-1002-
-Final HOPE-2 Data Now Expected by Mid-Q2-
LOS ANGELES, April 13, 2020 (GLOBE NEWSWIRE) -- Capricor Therapeutics (CAPR) a clinical-stage biotechnology company focused on the development of first-in-class biological therapeutics for the treatment or prevention of serious diseases, today announced that it will host a Key Opinion Leader (KOL) call on the cardiac complications of DMD on Wednesday, April 15, 2020 at 1:30 pm Eastern Time.
The call will feature a presentation by key opinion leader Michael Taylor, M.D., Ph.D. (Cincinnati Children's Hospital), Director of Advanced Imaging Innovation. Dr. Taylor will provide an overview of Duchenne muscular dystrophy, particularly focusing on the cardiac complications of the disease, its progression and current cardiac treatment options. Dr. Taylor will be available to answer questions at the conclusion of the call. Capricor’s management team will also provide an overview of the Company’s lead candidate, CAP-1002, a cell therapy that is currently in clinical development for the treatment of DMD.
Linda Marbán, Ph.D., chief executive officer of Capricor Therapeutics, said, "We plan to announce final 12-month data from our HOPE-2 study by the middle of the second quarter as all patient visits have now been completed. Based on the positive results we saw at 6 months, we are hopeful that the data will remain strong at 12 months after active patients will have received up to four doses of CAP-1002 over the course of one year. Although we recognize the challenges we all face in the midst of the international COVID-19 pandemic, we remain committed to our goal of advancing our therapeutic for patients with DMD and look forward to working with the FDA after receipt of this data with the goal of bringing this therapeutic to patients as quickly as possible.”
The FDA has granted Capricor’s CAP-1002 RMAT (Regenerative Medicine Advanced Therapy), Orphan Drug, and Rare Pediatric Disease designations.
Conference Call Details
Wednesday, April 15th @ 1:30pm Eastern Time
About Michael Taylor, M.D., Ph.D.
Michael Taylor, M.D., Ph.D., is a pediatric cardiologist at Cincinnati Children’s Hospital Medical Center where he directs the cardiac MR program. In collaboration with the Cincinnati Children’s multi-disciplinary neuromuscular center, his group has performed over 1000 cardiac MR studies in DMD patients for both clinical care and research investigation. He has published papers on cardiac function, myocardial injury, and response to therapy in the Duchenne cardiomyopathy. Dr. Taylor joined the Heart Institute in 2010 as the director of Advanced Imaging Innovation and cardiac MR. He has expertise in cardiac magnetic resonance imaging of acquired and congenital heart disease in children and adults. He has a dual appointment in the Cincinnati Children's Hospital Medical Center Imaging Research Center, an interdisciplinary center dedicated to research MRI. Dr. Taylor's primary interests include cardiac MR and myocardial characterization, animal models of cardiac pathology, and novel MR techniques. He has an MD and PhD (physics) from the University of Wisconsin – Madison and post-doctoral training in pediatrics and cardiology at the Baylor College of Medicine.
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, or CDCs, a type of cardiac cell therapy that has been shown in pre-clinical and clinical studies to exert potent immunomodulatory activity and is being investigated for its potential to modify the immune system’s activity to encourage cellular regeneration. The cells function by releasing exosomes that are taken up largely by macrophages and T-cells and begin a cycle of repair. 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 or prevention of serious diseases. 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 is also investigating the field of extracellular vesicles and is exploring the potential of exosome-based candidates to treat or prevent 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, 2019 as filed with the Securities and Exchange Commission on March 27, 2020. 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. None of Capricor’s exosome-based candidates have been approved for clinical investigation.
For more information, please contact:
Joyce Allaire - Managing Director
LifeSci Advisors, LLC
AJ Bergmann, Chief Financial Officer