Trial Funded Through $3M Grant From National Institutes of Health
LOS ANGELES, CA, USA I January 12, 2015 I Capricor Therapeutics, Inc. (CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that the first three patients have been treated in its DYNAMIC clinical trial. The trial is being conducted by Dr. Raj Makkar and his colleagues at Cedars-Sinai Heart Institute in Los Angeles. The Phase I DYNAMIC trial, also known as the “Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells” trial, will evaluate CDCs (CAP-1002) in patients with advanced heart failure. The Phase I trial is being funded in part through a grant of approximately $3 million from the National Institutes of Health (NIH).
The Phase I trial will enroll 14 patients with either ischemic or non-ischemic dilated cardiomyopathy with left ventricular ejection fraction (LVEF) <= 35% and New York Heart Association (NYHA) Class III or Ambulatory Class IV heart failure. Suitable patients will undergo sequential intracoronary infusion (triple vessel infusion) of CAP-1002 in up to three coronary territories. The primary safety endpoints will be assessed at the 1-month visit. Safety and exploratory efficacy endpoints including ejection fraction, ventricular volumes and a six-minute walk test will be evaluated at both the 6 and 12 month follow-up. It is hoped that following the successful 14 patient lead-in phase of DYNAMIC, the safety results will support continuation to a subsequent phase that includes a randomized, control cohort.
Capricor is concurrently conducting the 300 patient, Phase II ALLSTAR trial with CAP-1002 in patients thirty days to one year following large myocardial infarctions (heart attack). ALLSTAR is designed to determine safety and effectiveness at scar size reduction of CAP-1002 in patients at high risk following myocardial infarction. Phase II of the ALLSTAR trial is being funded with the support of the California Institute for Regenerative Medicine.
DYNAMIC Principal Investigator, Dr. Raj Makkar commented, “DYNAMIC represents the next significant step forward in the study of CDCs in patients with heart disease. ALLSTAR is studying patients treated within one year of a large heart attack but not yet severely symptomatic. DYNAMIC is studying a much more ill cohort who suffer from clinically relevant, advanced heart failure. We are hopeful that these studies will provide evidence for the role of CDCs across a broad spectrum of heart disease.”
Dr. Linda Marban, Capricor CEO added, “We are extremely excited to begin this clinical trial with the support of the NIH as it further advances the CAP-1002 development strategy. With heart failure affecting over 5 million people in the United States alone and the annual costs for treatment estimated to be in the multiple billions annually, there is a clear need for novel and effective treatments. In conjunction with our Cenderitide program, Capricor is well positioned in the field of heart failure.”
For more information, please visit: http://capricor.com/clinical-trials/dynamic/.
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 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.
SOURCE: Capricor Therapeutics
Post Views: 36
Trial Funded Through $3M Grant From National Institutes of Health
LOS ANGELES, CA, USA I January 12, 2015 I Capricor Therapeutics, Inc. (CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that the first three patients have been treated in its DYNAMIC clinical trial. The trial is being conducted by Dr. Raj Makkar and his colleagues at Cedars-Sinai Heart Institute in Los Angeles. The Phase I DYNAMIC trial, also known as the “Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells” trial, will evaluate CDCs (CAP-1002) in patients with advanced heart failure. The Phase I trial is being funded in part through a grant of approximately $3 million from the National Institutes of Health (NIH).
The Phase I trial will enroll 14 patients with either ischemic or non-ischemic dilated cardiomyopathy with left ventricular ejection fraction (LVEF) <= 35% and New York Heart Association (NYHA) Class III or Ambulatory Class IV heart failure. Suitable patients will undergo sequential intracoronary infusion (triple vessel infusion) of CAP-1002 in up to three coronary territories. The primary safety endpoints will be assessed at the 1-month visit. Safety and exploratory efficacy endpoints including ejection fraction, ventricular volumes and a six-minute walk test will be evaluated at both the 6 and 12 month follow-up. It is hoped that following the successful 14 patient lead-in phase of DYNAMIC, the safety results will support continuation to a subsequent phase that includes a randomized, control cohort.
Capricor is concurrently conducting the 300 patient, Phase II ALLSTAR trial with CAP-1002 in patients thirty days to one year following large myocardial infarctions (heart attack). ALLSTAR is designed to determine safety and effectiveness at scar size reduction of CAP-1002 in patients at high risk following myocardial infarction. Phase II of the ALLSTAR trial is being funded with the support of the California Institute for Regenerative Medicine.
DYNAMIC Principal Investigator, Dr. Raj Makkar commented, “DYNAMIC represents the next significant step forward in the study of CDCs in patients with heart disease. ALLSTAR is studying patients treated within one year of a large heart attack but not yet severely symptomatic. DYNAMIC is studying a much more ill cohort who suffer from clinically relevant, advanced heart failure. We are hopeful that these studies will provide evidence for the role of CDCs across a broad spectrum of heart disease.”
Dr. Linda Marban, Capricor CEO added, “We are extremely excited to begin this clinical trial with the support of the NIH as it further advances the CAP-1002 development strategy. With heart failure affecting over 5 million people in the United States alone and the annual costs for treatment estimated to be in the multiple billions annually, there is a clear need for novel and effective treatments. In conjunction with our Cenderitide program, Capricor is well positioned in the field of heart failure.”
For more information, please visit: http://capricor.com/clinical-trials/dynamic/.
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 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.
SOURCE: Capricor Therapeutics
Post Views: 36
