Bioheart, Inc. Expands Clinical Trials of Adult Myogenic Stem Cell Treatment for Heart Attack and Advanced Heart Failure Patients

Nov 16, 2006, 00:00 ET from Bioheart, Inc.

    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.
 
 

SOURCE Bioheart, Inc.
    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.
 
 SOURCE Bioheart, Inc.