Capricor Therapeutics Inc (CAPR)

[CDut1]

Capricor Therapeutics Announces Plans to Pursue a Cenderitide Clinical Program and Enters Into Research Support Agreement With Insulet Corporation
Clinical Trial Expected to Commence in Early 2015 Using the Insulet Delivery Technology

LOS ANGELES, Oct. 9, 2014 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that it plans to develop a clinical program using Cenderitide for the treatment of post-acute heart failure using Insulet's drug delivery system based on the OmniPod(R) insulin management system.

Additionally, Capricor announced that it has entered into an Investigator-Initiated Research Support Agreement (the "Agreement") with Insulet Corporation (PODD). Pursuant to the Agreement, Insulet will support Capricor's research by engaging in certain product development, project management and design control activities in addition to product supply for the planned clinical trial.

Dr. Linda Marban, Chief Executive Officer of Capricor, said, "Recent positive results in Novartis' PARADIGM-HF trial have shown 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 believe this validates the mechanism of action of Cenderitide, which is a dual receptor natriuretic peptide agonist. We intend to develop Cenderitide as an outpatient therapy to be delivered continuously for up to 90 days after discharge from the hospital to patients who have been admitted for acute decompensated heart failure (ADHF). There are currently no treatments on the market that specifically target the stabilization and reduction of the early re-hospitalization rate of acute decompensated heart failure patients."

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 in one month, and 50% are re-hospitalized in six months.

Dr. Linda Marban, continued, "These staggering statistics, coupled with the prevalence and incidence of heart failure increasing around the world, leads us to believe this could be an extremely exciting market opportunity for Capricor. We are pleased to announce our pursuit of this key clinical program with Insulet's support as we continue to execute on our strategy to bring Cenderitide back into the clinic. We are planning a clinical trial to commence in early 2015. Of note, we have been granted Fast-Track designation by the FDA for the post-acute development program for Cenderitide."

Currently, there are no drugs on the market targeting the post-acute period, 90 days following a hospital admission for Acute Decompensated Heart Failure (ADHF). Cenderitide's treatment goal and target indication is prevention of re-hospitalization in heart failure patients during the post-acute hospitalization period.

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