Capricor Therapeutics Cleared to Begin Phase II Portion of ALLSTAR Clinical Trial with CAP-1002 in Patients Following Heart A...
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Capricor Therapeutics, Inc. (USOTC:NLTXD)
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Capricor Therapeutics, Inc. (OTCBB: NLTXD) today announced that it has received notification from the National Heart Lung and Blood Institute (NHLBI) Gene and Cell Therapy (GST) Data Safety Monitoring Board (DSMB) that the 14-patient Phase I portion of the Company’s ALLSTAR Phase I/II clinical trial has met its safety endpoints and that the Company is now cleared to begin the Phase II portion of the ALLSTAR clinical trial.
Capricor’s ALLSTAR Phase I/II clinical trial is evaluating its CAP-1002 allogeneic cardiac-derived cell (CDC) product candidate in reducing infarct (scar) size in patients who have suffered a heart attack. The estimated 300-patient, double-blind, randomized, placebo-controlled Phase II portion of the ALLSTAR clinical trial is powered to detect a reduction in infarct size as measured by MRI in patients following a large myocardial infarction more than 30 days and less than 12 months prior to treatment with CAP-1002. The trial is sub-randomized into an ‘early’ group (30-90 days post-heart attack) and a ‘late’ group (91-365 days post-heart attack). Each group is powered sufficiently to provide both a safety and efficacy readout. Phase I of the ALLSTAR trial was funded in part by a grant received from the NIH. Phase II is being funded with the support of the California Institute for Regenerative Medicine.
“The fact that donor heart CDC cells were introduced into patients following a myocardial infarction and produced no adverse clinical effects in the 14-patient Phase I cohort marks a major milestone for the field of cardiac cell therapy,” said Timothy D. Henry, MD, Co-Principal Investigator of ALLSTAR and Chief of Cardiology at Cedars Sinai Medical Center in Los Angeles. “We are excited about entering the randomized portion of the trial and probing both the safety and effectiveness of these cardiac-derived allogeneic stem cells in a larger group of patients.”
Capricor CEO Dr. Linda Marbán stated, “Meeting the safety endpoints in the Phase I portion of the ALLSTAR trial is a giant leap forward for the field and for Capricor Therapeutics. By moving into the Phase II portion of this trial, we can now attempt to replicate the results of the previously conducted Phase Ib CADUCEUS autologous trial in a larger population using the significantly less expensive allogeneic cells.”
In the prospective, randomized Phase I Intracoronary Cardiosphere-Derived Cells for Heart Regeneration after Myocardial Infarction (CADUCEUS) clinical trial, 24 patients received CDC treatment. The trial provided early evidence for cardiac regeneration as autologous CDC patients saw scars left by myocardial infarction shrink over the course of 12 months and scientists observed a significant correlation between scar shrinkage and increases in viable tissue suggesting regeneration of new viable heart muscle. CDC patients also demonstrated improved regional function and trends pointing toward the reversal of adverse cardiac remodeling.
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 will begin trading under the symbol “CAPR” starting December 20, 2013. For additional information visit www.capricor.com.
About CAP-1002
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.
About Cenderitide
Cenderitide, a novel chimeric natriuretic peptide, is a first-in-class dual guanylyl cyclase receptor activator. Chronic dual receptor activation using a continuous subcutaneous infusion of Cenderitide is being studied to test whether its combination of tissue protective, renal protective and cardiac unloading effects will help stabilize the patient’s heart and kidney function, preventing the worsening of heart failure symptoms and re-admissions to the hospital. Cenderitide is under clinical development to treat heart failure patients during the post-acute heart failure (P-AHF) period, which is the 90-day period immediately after discharge from a hospitalization for acute decompensated heart failure. The P-AHF period is often associated with a worsening of heart failure symptoms or renal function and rates of re-admission and mortality can be as high as 40%.
Cenderitide is currently not an approved product and is strictly for investigational purposes.
