LOS ANGELES, March 31, 2015 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (Nasdaq:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that it has completed enrollment of its first Phase II clinical trial of Cenderitide in ambulatory heart failure patients. Cenderitide is in development for the outpatient treatment of patients following an acute admission for heart failure, as well as other potential indications.
The trial completed enrollment of 14 patients. Patients received up to eight consecutive days of increasing doses of Cenderitide by continuous subcutaneous infusion using Insulet's OmniPod® drug delivery system. The trial assessed the safety, tolerability, pharmacokinetic profile and pharmacodynamic response to increasing dose levels of open-label Cenderitide administered in a stepwise fashion, with each patient receiving the entire range of doses.
"This Phase II trial is an important step in our clinical development program aimed at treating heart failure patients on an outpatient basis," said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. "Given the enormous unmet clinical need and heart failure being responsible for over 1 million hospital admissions annually and the staggering re-admission rates for these patients, the goal of this trial is to develop the potential use of Cenderitide as a therapy for patients with clinically advanced heart failure. We believe that, if approved, Cenderitide administered via a patch pump delivery system such as the OmniPod® drug delivery system could keep patients out of the hospital and potentially lower overall costs on the healthcare system. Cenderitide is a dual receptor natriuretic peptide and recent positive results in Novartis' PARADIGM-HF trial have shown that the mechanism of action of their ARNI (angiotensin receptor neprilysin inhibitor) can raise the level of endogenous natriuretic peptides by preventing their enzymatic breakdown in chronic heart failure patients. We look forward to reporting on top line data from this trial during the second half of 2015 and announcing further clinical development plans in the coming months."
According to the American Heart Association, heart failure is the leading cause of hospitalization among adults older than 65 years of age in the United States and is responsible for over 1 million hospital admissions annually. Among those patients that have been admitted, approximately 24% are re-hospitalized within one month, and 50% are re-hospitalized within six months. Additionally, the Affordable Care Act may not allow Medicare payments for heart failure re-hospitalizations within 30 days.
Cenderitide belongs to a class of drugs called natriuretic peptides. Preclinical and clinical data have shown that the natriuretic peptide class can act on multiple disease processes that play a role in negative outcomes associated with heart failure. Cenderitide is in development for the outpatient treatment of patients following an acute admission for heart failure, as well as other potential indications. Cenderitide was designed by scientists at the Mayo Clinic to be the only dual natriuretic peptide receptor agonist. Cenderitide is currently not an approved product and is strictly for investigational purposes.
For more information on Cenderitide: http://capricor.com/product-pipeline/cenderitide-product/
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. For additional 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 conduct, size, timing and results of discovery efforts and clinical trials; scope, duration, validity and enforceability of intellectual property rights; 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," "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 Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on March 16, 2015, and in our Registration Statement on Form S-1, as filed with the Securities and Exchange Commission on March 6, 2015. 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.
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