Howard J. Leonhardt - Founder, Executive Chairman & Chief Technology Officer [HLeonhardt@aol.com]
MyoCell
MyoCell is a non-acute clinical therapy intended to improve cardiac function and designed to be utilized months and even years after a patient has suffered severe heart damage due to a heart attack or other cause. MyoCell uses myoblasts, cells which are precursors to muscle cells, cells that are precursors to muscle cells, or myoblast cells, from the patient's own body. When injected into scar tissue within the heart wall, myoblasts have shown to be capable of engrafting in the surrounding tissue and differentiating into mature skeletal muscle cells and/or cells which exhibit properties of both skeletal and cardiac muscle cells. As part of the MyoCell therapy, myoblasts are removed from a patient's thigh muscle, isolated, grown through our proprietary cell culturing process, and injected with a needle directly in the scar tissue of a patient's heart. We anticipate that an interventional cardiologist will perform the minimally invasive cell injection process with MyoCath, our proprietary catheter, or a similarly designed endoventricular catheter. By using myoblasts obtained from a patient's own body, we believe MyoCell is able to avoid certain challenges currently faced byother cell-based clinical therapies including tissue rejection and instances of the cells differentiating into cells other than muscle. Although a number of therapies have proven to improve the cardiac function of a damaged heart, no currently available treatment has demonstrated an ability to generate new muscle tissue within the scarred regions of a heart.
Interim data from the MYOHEART Trial and the SEISMIC Trial were presented by the lead investigator of each trial in January 2007 at the Third Annual International Conference on Cell Therapy for Cardiovascular Diseases and are described in greater detail below. The purpose of each trial is to assess the safety and efficacy of MyoCell delivered via MyoCath. The lead investigator for the MYOHEART Trial presented one-month safety data for all 20 of the treated patients, and three and six-month interim data for 16 of the 20 treated patients. Although not statistically significant due, in part, to the limited number of patients treated, the lead investigator indicated in his presentation that the safety of MyoCell is strongly suggested and the preliminary efficacy data demonstrates a trend towards an improvement in scores for six-minute walk distance, or Six-Minute Walk Distance, and an improvement in quality of life, or Quality of Life. The lead investigator for the SEISMIC Trial presented data for 16 treated patients and nine control group patients for which at least one-month follow-up data was available. He reported on three efficacy endpoints: Six-Minute Walk Distance scores, NYHA Class and left ventricular ejection fraction, or LVEF. The SEISMIC Trial's lead investigator noted that the preliminary efficacy trends appear encouraging and that the interim analysis suggests that the most frequent adverse event, irregular heartbeats, appears to be manageable with close observation and prophylactic use of ICDs and anti-arrhythmic drug therapy.
BIOHEART INC.
13794 NW 4th Street, Suite 212
Sunrise, Florida 33325
Tel: 954-835-1500
Fax: 954-845-9976
Email: hleonhardt@aol.com, csguck@bioheartinc.com.
BIOHEART INTERNATIONAL.
Physician Relations Europe, Middle East and Africa Sales and Marketing, Clinical Technical Support, Distribution.
Address: Raiffeisenallee 6
82041 Deisenhofen / Munich
Germany
Tel: +49 89 666 5810
Fax: +49 89 613 6006
Email: BioheartIntl@aol.com
