Capricor Therapeutics to Present ALLSTAR Phase I Trial Data at ACC Annual Meeting 2014
Trial Met Primary Safety Endpoint; Currently Enrolling for Phase II
LOS ANGELES, March 28, 2014 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (OTCBB:CAPR), a biotechnology company focused on developing novel therapeutics to prevent and treat heart disease, today announced Co-founder and Scientific Advisory Board Chairman, Dr. Eduardo Marbán, M.D., Ph.D., will present at the American College of Cardiology 63rd Annual Scientific Session and Expo, taking place March 29-31, 2014 in Washington, DC. Dr. Marbán's presentation will highlight positive data demonstrating that the Phase I portion of the Company's ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR) Phase I/II trial met its primary endpoint of safety.
During the Cell Therapy Scientific Session (Session #736), Dr. Marbán will present on the "Clinical Trials of Allogeneic Cardiac Stem Cells Post-MI (ALLSTAR) and in Advanced Heart Failure (DYNAMIC)," including results from the completed Phase I cohort of the ALLSTAR trial, which evaluated the safety of the Company's lead heart failure product candidate CAP-1002, an allogeneic cardiosphere-derived stem cell (CDC), in patients who have suffered a myocardial infarction (MI).
The open-label, dose escalation Phase I cohort evaluated 14 total patients (nine patients with recent MI; five patients with chronic MI) who were treated with CAP-1002 delivered via the intracoronary artery. The primary endpoint of the cohort was safety at one month post-infusion of CAP-1002. Results showed no acute myocarditis attributable to CAP-1002, no death due to ventricular tachycardia (VT) or ventricular fibrillation (VF), no sudden death and no major adverse cardiac events. Furthermore, Capricor investigated patients' immunology response to CAP-1002 and found that antibody response monitoring using donor specific antibodies (DSA) revealed low levels of antibodies present in treated patients, indicating relatively low immune responses triggered upon treatment with the allogeneic CDC therapy. In addition, no clinical sequelae (acute myocarditis, left ventricular dysfunction) were observed and cellular response monitoring revealed no de novo responses.
Based on these data, the National Institute of Health (NIH) Data and Safety Monitoring Board (DSMB) has approved the advancement of CAP-1002 to the double-blinded, randomized, placebo-controlled Phase II cohort of the ALLSTAR clinical trial, which is currently underway and actively enrolling patients.
|Details of Dr. Eduardo Marbán's presentation include:|
|Session:||Cell Therapy, #736|
|Presentation:||Clinical Trials of Allogeneic Cardiac Stem Cells Post-MI (ALLSTAR) and in Advanced Heart Failure (DYNAMIC)|
|Presenter:||Dr. Eduardo Marbán, M.D., Ph.D., FACC|
|Date:||Saturday, March 29, 2014|
|Time:||4:45 -- 6:00 p.m. EDT|
Dr. Linda Marbán, Ph.D., Chief Executive Officer of Capricor Therapeutics, said, "As a pioneer in cardiac regenerative medicine, Dr. Eduardo Marbán has been instrumental in the research and development of our allogeneic, off-the-shelf cardiosphere-derived stem cells. Coupled with findings from our autologous CDC study CADUCEUS, which demonstrated reduced scar size and increased healthy heart muscle, these ALLSTAR Phase I safety data further support the clinical development of CAP-1002 as a viable potential treatment for patients who have suffered a myocardial infarction. Collectively, our research to date further positions Capricor for success in the development of innovative cell therapies for heart failure, one of the largest segments of the cardiovascular field. We look forward to continuing the development of CAP-1002 by evaluating its efficacy through the currently enrolling Phase II portion of the ALLSTAR clinical program."
About Capricor Therapeutics
Capricor Therapeutics, Inc. (CAPR), a publicly traded biotechnology company, is focused on the development of novel therapeutics to prevent and treat heart disease. The Company has two leading product candidates: CAP-1002 and Cenderitide. The Company was formed through the November 2013 merger between Capricor, Inc., a privately held company whose mission is to improve the treatment of heart disease by commercializing cardiac stem cell therapies for patients, and Nile Therapeutics, Inc., a clinical-stage biopharmaceutical company developing innovative products for the treatment of cardiovascular diseases. Capricor Therapeutics' stock began trading under the symbol "CAPR" December 20, 2013. For additional information visit www.capricor.com.
CAP-1002, Capricor's lead product candidate, is a proprietary allogeneic adult stem cell therapy for the treatment of heart disease. The product is derived from donor heart tissue. The cells are expanded in the laboratory using a specialized process and then introduced directly into a patient's heart via infusion into a coronary artery using standard cardiac catheterization techniques.
CAP-1002 is currently not an approved product and is strictly for investigational purposes.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the conduct, size, timing and results of discovery efforts and clinical trials; plans regarding regulatory filings, future research and clinical trials; plans regarding current and future collaborative activities and the ownership of commercial rights; future royalty streams, 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," "plans," "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 our business are set forth in our Form 10-K for the year ended December 31, 2012, as filed with the Securities and Exchange Commission on June 21, 2013, in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, as filed with the Securities and Exchange Commission on November 14, 2013, and in our Definitive Proxy Statement on Schedule 14A, as filed with the Securities and Exchange Commission on October 10, 2013. All forward-looking statements in this press release are based on information available to us as of the date hereof, and we assume no obligation to update these forward-looking statements.
CONTACT: Capricor Therapeutics, Inc. AJ Bergmann, VP of Finance +1-310-358-3200 email@example.com The Ruth Group Lee Roth (investors) firstname.lastname@example.org (646) 536-7012 Kirsten Thomas (media) email@example.com (646) 536-7014Source: Capricor Therapeutics
Released March 28, 2014