-- MyoCell(R) Clinical Cell Therapy: Currently the subject of Bioheart's MARVEL Trial, a Phase II/III randomized, double-blind, placebo-controlled clinical trial, which involves 35 U.S. clinical sites, up from the five U.S. sites that participated in Bioheart's Phase I MYOHEART Trial. The trial is scheduled to enroll up to 330 patients and is the largest clinical trial of its kind ever undertaken.
-- Positive Clinical Results: Final clinical results of the Phase I MYOHEART Trial and Phase II-a SEISMIC Trial were presented at multiple major medical and scientific meetings this past year. In these studies, it was reported that 83 percent of patients treated with MyoCell(R) Therapy improved, or did not worsen, in the six-minute walk scores, while only 17 percent worsened. Additionally, in the SEISMIC Trial, 94 percent of patients treated with MyoCell(R) Therapy experienced improved or unchanged NYHA classification, while only six percent worsened. By comparison, 42 percent of the control group patients in the SEISMIC Trial, who received drug therapy alone, experienced a worsened NYHA classification. Both the six-minutes walk exercise test and quality of life scores are primary end points of MARVEL Trial.
-- MyoCell(R) SDF-1, intended to be an improvement of MyoCell(R) and being developed in collaboration with the University of Florida utilizing intellectual property licensed by the Cleveland Clinic, demonstrated positive functional improvement in two separate animal studies. Bioheart is preparing to enter into clinical registry studies in Switzerland and is working with the FDA on obtaining an IND for clinical trials in the U.S.
-- Bioheart TGI-1200(TM) System, a bedside apparatus f
|SOURCE Bioheart, Inc.|
Copyright©2008 PR Newswire.
All rights reserved