LOS ANGELES, CA, USA I September 18, 2014 I Capricor Therapeutics, Inc. (CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, presented an abstract entitled “ALLogeneic Heart STem Cells To Achieve Myocardial Regeneration (ALLSTAR): The Six Month Phase I Safety Results” with an oral presentation by Dr. Raj R. Makker, M.D., of Cedars-Sinai Medical Center, at the Transcatheter Cardiovascular Therapeutics (TCT) conference at the Walter E. Washington Convention Center, Washington, DC on September 16, 2014.
The first-in-human Phase I ALLSTAR trial was designed to test the safety and feasibility of intracoronary infusion of allogeneic cardiosphere-derived cells (CAP-1002) in patients with a previous anterior myocardial infarction (MI), within the prior 12 months, with infarct (scar) size >15% by MRI.
MRI data collected on the patients in the open-label dose-escalation study revealed that those patients who would be included in the Phase II clinical study, by virtue of dose and tissue type compatibility, show an increase in ejection fraction by 5.2% and a relative reduction in scar size of 20.7% at 12-month follow-up. The presentation highlighted that intracoronary infusion of allogeneic cardiosphere-derived cells (CAP-1002) appears to be safe and on track for demonstrating efficacy. Ongoing safety follow-up of Phase I subjects continues to reflect a favorable profile. The presentation of the available 12-month data will be held at a meeting of the American Heart Association on November 15-19, 2014 in Chicago, Illinois. Phase I was funded in large part by a grant received from the NIH. Phase II, which is currently enrolling, is funded with the support of the California Institute for Regenerative Medicine. The overall primary efficacy endpoint of Phase II will be scar size reduction at one year.
“We are pleased to have been selected to present results of our Phase I ALLSTAR trial at TCT,” said Capricor CEO, Linda Marban, Ph.D. “Our Phase I study indicates we are on track with both safety and feasibility, and favorable efficacy data continues to be compiled. We are also grateful to all the clinical investigators at Cedars-Sinai Heart Institute, The Minneapolis Heart Institute and The Scripps Research Institute, who continue to conduct our innovative clinical trials.”
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.
SOURCE: Capricor Therapeutics
Post Views: 255
LOS ANGELES, CA, USA I September 18, 2014 I Capricor Therapeutics, Inc. (CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, presented an abstract entitled “ALLogeneic Heart STem Cells To Achieve Myocardial Regeneration (ALLSTAR): The Six Month Phase I Safety Results” with an oral presentation by Dr. Raj R. Makker, M.D., of Cedars-Sinai Medical Center, at the Transcatheter Cardiovascular Therapeutics (TCT) conference at the Walter E. Washington Convention Center, Washington, DC on September 16, 2014.
The first-in-human Phase I ALLSTAR trial was designed to test the safety and feasibility of intracoronary infusion of allogeneic cardiosphere-derived cells (CAP-1002) in patients with a previous anterior myocardial infarction (MI), within the prior 12 months, with infarct (scar) size >15% by MRI.
MRI data collected on the patients in the open-label dose-escalation study revealed that those patients who would be included in the Phase II clinical study, by virtue of dose and tissue type compatibility, show an increase in ejection fraction by 5.2% and a relative reduction in scar size of 20.7% at 12-month follow-up. The presentation highlighted that intracoronary infusion of allogeneic cardiosphere-derived cells (CAP-1002) appears to be safe and on track for demonstrating efficacy. Ongoing safety follow-up of Phase I subjects continues to reflect a favorable profile. The presentation of the available 12-month data will be held at a meeting of the American Heart Association on November 15-19, 2014 in Chicago, Illinois. Phase I was funded in large part by a grant received from the NIH. Phase II, which is currently enrolling, is funded with the support of the California Institute for Regenerative Medicine. The overall primary efficacy endpoint of Phase II will be scar size reduction at one year.
“We are pleased to have been selected to present results of our Phase I ALLSTAR trial at TCT,” said Capricor CEO, Linda Marban, Ph.D. “Our Phase I study indicates we are on track with both safety and feasibility, and favorable efficacy data continues to be compiled. We are also grateful to all the clinical investigators at Cedars-Sinai Heart Institute, The Minneapolis Heart Institute and The Scripps Research Institute, who continue to conduct our innovative clinical trials.”
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.
SOURCE: Capricor Therapeutics
Post Views: 255
