Bioheart, Inc. (OTCBB:BHRT) announced today that Bioheart's primary focus is on completing clinical evaluation of its cell therapies for treating heart failure and related cardiac diseases.
Kristin Comella, Chief Scientific Officer of Bioheart, stated today, "We have FDA approval for two landmark clinical trials: the Phase II/III MARVEL study for MyoCell and the REGEN Phase I Dose Escalation Study for our 2nd generation product MyoCell SDF-1. Thirty-five U.S. centers have signed up to participate in the MARVEL study which is intended to enroll 160 patients. These two studies focus on Class III heart failure patients."
Bioheart recently announced plans to initiate a third study that has been dubbed: the LVAD + Cell Bridge to Recovery Phase I/II study in Class IV advanced heart failure patients. An advisory board consisting of prominent doctors in the U.S. has recommended three study groups: Group 1 = MyoCell SDF-1, Group 2 = MyoCell with 3 injection sessions, Group 3 = LVAD patients only. The LVAD + Cells Bridge to Recovery trial is intended to permit the treatment of the patients that are in most need of recovery of their myocardial scar tissue. The LVAD or left ventricular assist device serves to keep the patient alive during the time required to grow a sufficient volume of new contractile muscle within their heart with MyoCell injections. LVADs, like pacemakers or drugs, do not convert scar tissue back into living contracting muscle. Only myoblast injections are able to grow new muscle fibers. The intention is to complete this study in partnership with an LVAD company.
In addition to these U.S. trials, Bioheart has two Centers of Excellence which are focused on treating patients using adipose derived stem cells. The center in Mexico has recently completed 6 months follow up on the first 4 heart failure patients. These patients have demonstrated on average, an absolute improvement of 13 percentage points in ejection fraction and an increase of 100 meters in their 6 minute walk distance. The cells are delivered directly into the heart using Bioheart's MyoCath injection catheter. In the fourth quarter of last year, a shelf life validation study was completed on the current lot of MyoCath catheters confirming the long term stability of the product.
Bioheart has also partnered with the University Hospital Ostrava which is currently enrolling and treating end stage critical limb patients who have been listed on the amputation list. These patients are being treated with adipose derived stem cells in the Czech Republic Center of Excellence. Recently reported follow up showed that 75% of the patients demonstrated healing and pain reduction while only 25% of the patients required amputation.
Mike Tomas, President and CEO of Bioheart, stated, "We are committed to bringing these therapies to patients who need them and intend to continue these clinical trials."
Bioheart has been treating patients with cell therapy since 2001 and continues to lead the field with ground breaking trials and results:
- Over 300 patients have been enrolled in myoblast therapy for heart failure clinical trials since 2000.
- 84% of MyoCell treated patients have exhibited improvement while only 16% have worsened.
- In Bioheart's Phase II SEISMIC study 94% of treated patients improved in heart failure class while only 6% worsened.
- In Bioheart's Phase II/III MARVEL part I study, MyoCell treated patients improved 91.7 meters in exercise capacity testing while placebo patients on optimal heart failure drugs declined 4 meters.
- Pre-clinical studies at both Cleveland Clinic and the University of Florida demonstrated a 54% cardiac improvement in MyoCell SDF-1 treated animals, 27% with MyoCell and a 10% decline in placebo injected animals. Histopathological examinations showed a greater volume of new muscle and new mature blood vessels in the MyoCell SDF-1 treated myocardial scars than in the other two groups.
Study: 40% of newly diagnosed heart failure patients also have atrial fibrillation