SUNRISE, FL, USA I July 2, 2013 I Bioheart, Inc. (OTCQB: BHRT) announced today the successful enrollment and randomization of the first patient in the Phase III MIRROR Trial using MyoCell® or muscle derived stem cells.
The MIRROR trial is fully funded by Bioheart and will be conducted at up to 35 centers in North and South America. The trial is designed to enroll up to 126 patients over a 12 month time period. The first patient has been enrolled in Mexico at the Hospital Angeles with the Regenerative Medicine Institute (RMI). This study will complement the data completed in the Phase II/III MARVEL trial on patients with congestive heart failure (CHF). Patients are randomized into either the treatment (2/3) or placebo (1/3) arm. All patients will receive delivery into the damaged areas of the heart using the MyoCath® Catheter. Data endpoints will include safety, exercise capacity, quality of life, and ejection fraction at 3 months and 6 months. Kristin Comella, Bioheart’s Chief Science Officer, said, “We are hoping to achieve results similar to those from the MARVEL trial in which patients improved almost 100 meters over placebo in their exercise capacity test. We believe this therapy can address an unmet need for cardiac patients.”
The FDA has placed a hold on the request for an Expanded Access protocol using MyoCell in part because the proposed expanded access study would likely interfere with the clinical development of MyoCell and/or interfere with developing market approval. Bioheart intends to continue enrollment in the MIRROR trial while hold items are addressed with the FDA. In addition, Bioheart plans to initiate part 2 of the MARVEL trial using the J&J MyoStar™ Catheter to deliver MyoCell to CHF patients.
About Bioheart, Inc.
Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart’s goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient’s quality of life and reduce health care costs and hospitalizations.
Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient’s heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit www.bioheartinc.com, or visit us on Facebook: Bioheart and Twitter @BioheartInc.
SOURCE: Bioheart
Post Views: 181
SUNRISE, FL, USA I July 2, 2013 I Bioheart, Inc. (OTCQB: BHRT) announced today the successful enrollment and randomization of the first patient in the Phase III MIRROR Trial using MyoCell® or muscle derived stem cells.
The MIRROR trial is fully funded by Bioheart and will be conducted at up to 35 centers in North and South America. The trial is designed to enroll up to 126 patients over a 12 month time period. The first patient has been enrolled in Mexico at the Hospital Angeles with the Regenerative Medicine Institute (RMI). This study will complement the data completed in the Phase II/III MARVEL trial on patients with congestive heart failure (CHF). Patients are randomized into either the treatment (2/3) or placebo (1/3) arm. All patients will receive delivery into the damaged areas of the heart using the MyoCath® Catheter. Data endpoints will include safety, exercise capacity, quality of life, and ejection fraction at 3 months and 6 months. Kristin Comella, Bioheart’s Chief Science Officer, said, “We are hoping to achieve results similar to those from the MARVEL trial in which patients improved almost 100 meters over placebo in their exercise capacity test. We believe this therapy can address an unmet need for cardiac patients.”
The FDA has placed a hold on the request for an Expanded Access protocol using MyoCell in part because the proposed expanded access study would likely interfere with the clinical development of MyoCell and/or interfere with developing market approval. Bioheart intends to continue enrollment in the MIRROR trial while hold items are addressed with the FDA. In addition, Bioheart plans to initiate part 2 of the MARVEL trial using the J&J MyoStar™ Catheter to deliver MyoCell to CHF patients.
About Bioheart, Inc.
Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart’s goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient’s quality of life and reduce health care costs and hospitalizations.
Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient’s heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit www.bioheartinc.com, or visit us on Facebook: Bioheart and Twitter @BioheartInc.
SOURCE: Bioheart
Post Views: 181
