SUNRISE, Fla., Nov. 16 /PRNewswire-FirstCall/ -. Bioheart, Inc., a biotechnology company focused on the development of innovative cell therapies designed to repair areas of damaged muscle tissue in a patient’s heart and improve cardiac function, is expanding its United States and European clinical trials of its MyoCell(TM) adult myogenic (muscle) stem cell composition and MyoCath(R) needle-injection catheter product candidates. MyoCell(TM) is a non-acute, clinical therapy for treatment of damage to the heart in patients in Class II or Class III heart failure. Bioheart believes that its MyoCell(TM) therapy has the potential to become a leading non-acute treatment for severe damage to the heart due to its perceived ability to satisfy a presently unmet demand for more effective and/or more affordable non-acute therapies for heart damage.
“After more than 19 years of development and testing, large scale clinical studies are being expanded by statistically significant numbers with an additional 450 plus patients,” stated Michael Brown, M.D., Ph.D., Bioheart’s Senior Clinical Scientist. “We are excited about advancing our therapy and possibly bringing its benefits to more patients,” he added.
In the United States, Bioheart completed enrollment in the fourth and final cohort of its dose escalation Phase I clinical trial, known as the MYOHEART trial. In this final, cohort of the MYOHEART study, patients received a high-dose injection of 675 million cells, as compared to 25, 75 and 225 million cell doses tested in previous cohorts. Interim analysis of this data was recently published in the August 2006 issue of the Journal of Cardiac Failure, and this data was also presented at the 10th annual meeting of the Heart Failure Society of America that was held in September 2006. In October 2006, Bioheart finalized the proposed protocol for its United States Phase II randomized double-blind, placebo-controlled MYOHEART II clinical study and has submitted this protocol to the United States Food and Drug Administration for review. This study has been designed to enroll up to 450 patients at approximately 40 centers with the intended purpose of confirming the safety and efficacy of our adult myogenic stem cell transplantation for treating heart failure.
In Europe, Bioheart recently expanded its Phase IIa randomized clinical trial, known as the SEISMIC trial, from five clinical testing centers to twelve clinical testing centers. The added centers are in England, The Netherlands, Germany, Poland, Belgium, Mexico and Spain. Bioheart has also taken steps to initiate clinical trials in Switzerland, The Bahamas, Korea, Singapore, and South Africa by submitting registry trial protocols for approval to government and hospital institutional review boards in these countries. Bioheart utilizes certified cGMP cell culturing facilities in Europe and the United States to support these trials.
The original research for the Bioheart treatment approach was conducted in the late 1980’s and early 1990’s by some of its scientific advisory board members and research collaborators: Dr. Race Kao, Dr. Ray Chiu, Dr. Stuart Williams, Dr. Felipe Prosper, and Dr. Doris Taylor, who are all pioneers in cell transplantation research for the cardiac application. Bioheart began clinical studies utilizing percutaneous delivery of its MyoCell(TM) adult myogenic stem cell composition in Europe in early 2001. Since that time, more than 300 patients in various clinical trials worldwide have been treated with myogenic stem cell compositions covered by Bioheart licensed patents.
“We are pleased to announce the expansion of our MyoCell(TM) and MyoCath(R) product candidate clinical trials,” said Howard J. Leonhardt, Bioheart’s Chairman and CEO. “This expansion is made possible by our entire team being dedicated to helping patients who suffer from heart failure,” he added.
Data from Bioheart’s clinical and preclinical studies have been published in the Journal of the American College of Cardiology (December 2003), The Journal of Heart and Lung Transplantation (November 2005), Nature Clinical Practice (March 2006) and numerous other peer-reviewed journals (Please see the Physician Resources section of our website at www.bioheartinc.com for a more complete listing). Additional updates and data from Bioheart’s preclinical studies and clinical trials were presented at the October 2006 TransCatheter Therapeutics Cardiology Meeting in Washington, D.C. and are anticipated to be presented at the Cell Therapy for Cardiovascular Diseases Meeting in New York, January 17-19, 2007.
About MyoCell(TM) and MyoCath(R)
MyoCell(TM) is an innovative cell-based therapy that uses myoblasts, or precursors to muscle cells, derived from a patient’s own thigh muscle to produce uniquely composed implants that are placed into the heart percutaneously (via cardiac catheter). When injected into scar tissue within the heart wall, myoblasts are capable of developing into contractile muscle cells and integrating with heart muscle and/or releasing potentially beneficial proteins. MyoCath(R), a proprietary catheter delivery system, is designed to deliver cell therapy or other compounds directly into the heart muscle through needle injection.
About Bioheart
For more information about Bioheart, please visit http://www.bioheartinc.com or contact Mr. Jason Griffeth by telephone at (954) 835-1500 or by e-mail at jgriffeth@bioheartinc.com.
Bioheart, Inc.
CONTACT: Jason Griffeth of Bioheart, Inc., +1-954-835-1500, orjgriffeth@bioheartinc.com
Web site: http://www.bioheartinc.com//
