Bioheart, Inc. (OTCBB:BHRT), presented positive efficacy data from part 1 of its Phase II/III clinical trial at the Heart Failure Society of America (HFSA) Meeting in Boston, Massachusetts. Thomas Povsic, MD, Ph.D., Assistant Professor of Medicine at Duke University, presented the final data for Part 1 of the MARVEL Phase II/III Clinical Trial as a part of the Late Breaking Clinical Trials Session. Along with Dr. Povsic, Chris O'Connor, MD, Head of Heart Failure at Duke University and the study’s Principal Investigator Warren Sherman, MD, Director of Stem Cell Research and Regenerative Medicine at the Center for Interventional Vascular Therapy of Columbia University Medical Center, attended the presentation and fielded questions regarding the scientific and clinical implications of MARVEL Part 1.
In furthering its near-term goal of providing positive “pivotal data” of autologous skeletal myoblasts (ASM, or MyoCell®, Bioheart’s flagship biologic product), the MARVEL Program applies study designs that emphasize double-blind, placebo control strategies. Dr. Povsic’s presentation centered upon data from MARVEL Part 1, the first study of its kind to utilize catheter-based cell delivery in a double-blinded, placebo-controlled manner.
Patients in MARVEL Part 1, all of whom suffer from chronic heart failure and many of whom are also diabetic, were randomly assigned to three separate treatment groups: 1) 400 million cells, or 2) 800 million cells, or 3) placebo. Each injection (16 per patient) was administered directly into parts of the ventricular wall specifically weakened by scar tissue from previous heart attacks with the Myostar® device (Biologics Delivery Systems, Diamond Head, CA), a catheter with an established record of safety. The results presented by Dr. Povsic were based on analyses of 3 and 6-month follow-up data from 20 patients.
Over the 6-month observation period, the most pronounced changes were seen in the cell-treated groups. The 6 minute walk distance (6MWD, an established parameter of efficacy utilized in heart failure studies), one of the primary end points in the trial, increased on average by more than 91 meters in cell-treated patients, whereas in the placebo-treated group a decrease of nearly 4 meters was seen. This may suggest that patients with heart failure could return to a more active lifestyle after receiving Bioheart’s treatment. Moreover, important safety objectives were met. The occurrence of early (within 4 weeks of ASM implantation) ventricular tachyarrhythmias appeared in the ASM treated groups, similar to observations in other clinical trials involving heart failure patients. However, the arrhythmias were detected and treated with no adverse results, and disappeared in many cases early on and completely by six months post-treatment; the investigators believe that early detection and management strategies, as were implemented and refined during enrollment in MARVEL Part 1, reduce the risk of recurrent arrhythmias and may enhance 6-month event-free survival. There were no deaths in this study.
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