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
http://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.
SOURCE Bioheart, Inc.
 back to top
Related links:
http://www.bioheartinc.com/
CONTACT:
Jason Griffeth of Bioheart, Inc.,
+1-954-835-1500, or jgriffeth@bioheartinc.com
|
