Capricor Announces Enrollment of Its Phase II Clinical Trial for Cenderitide to Treat Heart Failure
Natriuretic Peptide to be Administered Subcutaneously in Ambulatory Heart Failure Patients
LOS ANGELES, March 5, 2015 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (OTCBB:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that it is currently enrolling a Phase II clinical trial with Cenderitide, a dual receptor natriuretic peptide agonist that has previously been used in approximately 270 patients including those suffering from acute decompensated heart failure. Capricor's current trial is a dose ranging study that is intended to evaluate the safety and feasibility of delivering the drug via a subcutaneous drug delivery patch pump. Capricor intends to address the large market for outpatient and ambulatory heart failure treatment including those patients with recent acute heart failure admissions as well as other potential indications.
The present trial will enroll up to 14 patients with stable, chronic heart failure. Currently, the first two cohorts of patients have completed dosing with the remaining subjects expected to be treated over the next month. Patients will receive up to eight consecutive days of Cenderitide through subcutaneous infusion using Insulet's drug delivery system based on the OmniPod® technology. This trial will assess the safety and tolerability, pharmacokinetics profiles, and pharmacodynamic response to increasing dose levels of open-label Cenderitide administered in a stepwise fashion with each patient getting the entire range of doses. Cenderitide's treatment goal and target indication is to provide a novel and effective therapeutic option for the outpatient treatment of heart failure thereby addressing a critical unmet need and one of the largest potential markets in medicine.
"We now enter a potentially new era for the outpatient treatment of heart failure by combining a precision drug delivery system with a very potent class of drugs that are natriuretic, anti-aldosterone and have positive effects on remodeling," said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. "There is need for treatments that improve outcomes for recently decompensated patients. With sobering heart failure statistics, this has the potential to be an extremely exciting market opportunity for Capricor. Given the efficacy data generated by Novartis's LCZ696, which acts by inhibiting the enzyme that degrades endogenous natriuretic peptides, we are hopeful that by administration of our therapeutic natriuretic peptide Cenderitide, we may achieve beneficial clinical effects."
Heart Failure
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. The Affordable Care Act may not allow Medicare payments for heart failure re-hospitalization within 30 days.
About Cenderitide
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 designed as an outpatient therapy to be delivered continuously using a validated subcutaneous infusion pump for up to 90 days (the "post-acute" period) following a hospital admission for ADHF. 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.
About Insulet Corporation
Insulet Corporation (Nasdaq:PODD) is an innovative medical device company primarily focused on making it easier for people living with diabetes to manage their disease. Through its OmniPod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes. The OmniPod is a revolutionary and easy-to-use tubeless pump that features just two parts and fully-automated cannula insertion. The OmniPod technology has also been adapted to deliver additional drugs in other disease states. Insulet has also developed variations of the OmniPod to allow for delivery of drugs to treat other medical conditions. Founded in 2000, Insulet Corporation is based in Billerica, Mass. For more information, please visit: http://www.myomnipod.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; 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 Form 10-K for the year ended December 31, 2013, as filed with the Securities and Exchange Commission on March 31, 2014, in our Amendment No. 1 to Registration Statement on Form S-1, as filed with the Securities and Exchange Commission on May 23, 2014, and in our Form 10-Q for the quarter ended September 30, 2014, as filed with the Securities and Exchange Commission on November 14, 2014. 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: For more information, please contact:
Corporate Contact
Capricor Therapeutics, Inc.
AJ Bergmann, Vice President of Finance
+1-310-358-3200
abergmann@capricor.com
Media Relations
Russo Partners
Christopher Hippolyte
+1-646-942-5634
chris.hippolyte@russopartnersllc.com
Tony Russo, Ph.D.
+1-212-845-4251
tony.russo@russopartnersllc.com
Investor Relations:
Russo Partners
Robert Flamm, Ph.D.
+1-212-845-4226
robert.flamm@russopartnersllc.com
Released March 5, 2015