Bioheart group to advance BRIDGE TO RECOVERY clinical trial

Dec 9 2010

Bioheart, Inc. (OTC Bulletin Board: BHRT) announced today that at the American Heart Association Annual Meeting, it finalized the formation of a working group. The group's focus is to advance a BRIDGE TO RECOVERY clinical trial, combining a left ventricle assist device (LVAD) and Bioheart's MyoCell adult muscle stem cell composition and Bioheart's MyoCath needle tipped catheter delivery system.  

The expected study design pending potential modification will include 3 treatment arms:

Group 1 - Patients receive MyoCell SDF-1 single dose via MyoCath catheter delivery after LVAD placement.

Group 2 - Patients receive MyoCell in multiple injection sessions over 6 months via MyoCath catheter delivery following LVAD placement.

Group 3 - Patients receive LVAD only.

The end points in the trial will include exercise capacity, functional improvements and success in weaning off the LVAD.

"At the AHA meeting, improvements in survival of heart failure patients were reported from trials with battery powered pacers and mechanical left ventricle assist heart pumps.  These devices help patients cope with their failing heart, but do little to repair damaged scar tissue in the heart, which is often the primary source of heart failure.  The MyoCell composition from Bioheart has demonstrated an ability to grow new contractile muscle in scar tissue and thus, may actually address the underlying problem.  Supporting the patient with an LVAD temporarily during the time period to make successive injections of muscle stem cells and progressively building up more new muscle over a 21-week period, makes great sense.   The hope of this trial is that, at the end of this period, the patients can have their LVADs explanted and return to a high quality of life," stated Dr. Carl Pepine, Director of Cardiology University of Florida and past President of the American College of Cardiology.  "The ability to recover back hearts that may go to transplant and to examine them fully adds extra scientific integrity to this proposed study design.  This study has the potential to be a landmark clinical trial in our field."

"We know that we can grow new strips of contractile muscle across myocardial scar tissue with each half hour minimally invasive injection session with our MyoCell.  After injections with MyoCell the patients hopefully will have enough strength that the LVAD can be removed.  The LVAD serves well to support these patients including reducing their risk of arrhythmias during the waited stages of muscle formation.  These two therapies together ideally complement each other," stated Howard J. Leonhardt, Founder of Bioheart, Inc., Chief Technology Officer and Chairman Scientific Advisory Board.

He further added, "Only myoblasts such as our MyoCell composition have demonstrated an ability to form surviving contractile muscle within scar tissue.  Cardiac stem cells, embryonic stem cells, bone marrow, blood, placenta, umbilical cord and adipose (fat) derived stem cells do not.  Most of these pluripotent stem cells become what they touch so in scar tissue they form fibroblasts or more scar tissue, not muscle like MyoCell does.  We believe Myoblasts are the ideal cell type for this application which this study is meant to further demonstrate."  

Bioheart's MyoCell has been in clinical trials for treating advanced heart failure since early 2001. The MyoCell composition is derived from selecting immature myoblasts (adult muscle stem cells) from a patient's own skeletal (thigh) muscle.  The process of selecting and expanding these cells is done in Bioheart's cGMP facility in Sunrise, Florida.  The cells are injected by a needle tipped catheter that is inserted through a very small puncture in the patient's groin through their femoral artery.  The catheter is directed to the inside of the left chamber of the heart where injections are made in the scar tissue within the heart.  Approximately 350 patients have been enrolled in various myoblast treated heart failure clinical trials since 2000.  Over 84% of MyoCell treated patients have exhibited improvement of symptoms while only 16% have declined.   Most recent Phase II/III results demonstrated MyoCell treated patients have improved 91.7 meters in exercise capacity testing while placebo injected patients declined – 4 meters.  

SOURCE Bioheart, Inc.