MyoCell SDF-1 similar to MyoCell

We anticipate that MyoCell SDF-1 will be similar to MyoCell, except that the myoblast cells to be injected will be modified prior to injection...More Info >

Phase 1 Clinical Trials

We filed an IND application in May 2007 for Phase I clinical trials of MyoCell
SDF-1 and received comments from the FDA in August and December 2007. More Info >

Product Candidates

Myocell SDF-1

myocell sdf1

Our MyoCell SDF-1 product candidate, which has recently completed preclinical testing, is intended to be an improvement to MyoCell. Bioheart has worked with the Cleveland Clinic and the University of Florida to develop the MyoCell SDF-1 technology. In addition, in connection with our establishment of the relationship with the Cleveland Clinic, Dr. Marc Penn, the Medical Director of the Cardiac IntensiveCare Unit at the Cleveland Clinic and a staff cardiologist in the Departments of Cardiovascular Medicine and Cell Biology, joined our Scientific Advisory Board.

We anticipate that MyoCell SDF-1 will be similar to MyoCell, except that the myoblast cells to be injected will be modified prior to injection by an adenovirus vector or a non-viral vector so that they will release extra quantities of the SDF-1 protein, which expresses angiogenic factors. Following injury which results in inadequate blood flow to the heart, such as a heart attack, the human body naturally increases the level of SDF-1 protein in the heart. By modifying the myoblasts to express SDF-1 prior to injection, we are seeking to increase the SDF-1 protein levels present in the heart. We are seeking to demonstrate that the presence of additional quantities of SDF-1 protein released by the myoblasts will stimulate the recruitment of the patient's existing stem cells to the cell transplanted area and, thereafter, the recruited stem cells will assist in the tissue repair and blood vessel formation process. Preclinical animal studies showed a definite improvement of cardiac function when the myoblasts were modified to express SDF-1 protein prior to injection as compared to when the myoblasts were injected without modification.

We filed an IND application in May 2007 for Phase I clinical trials of MyoCell SDF-1 and received comments from the FDA in August and December 2007. Assuming FDA approval of the protocol for a Phase I Trial of MyoCell SDF-1 in the second quarter of 2008 and our receipt of certain grants which we have applied for, we hope to begin enrolling patients in the Phase I Trial during such quarter.

Candidate	Proposed Use or Indication	Status/Phase
MyoCell® SDF-1	Autologous cell therapy treatment for severe chronic damage to the heart; cells modified to express angiogenic factors.	IND application filed in May 2007

Comments: Upon approval of IND application and receipt of grant approval, anticipate commencing Phase I clinical trials during the second quarter of 2008.