News | July 28, 2009

FDA Clears REGEN Trial to Test Gene/Stem Cell Therapy in Heart Failure Patients

July 28, 2009 – Bioheart Inc. today said the FDA cleared a phase I clinical trial for MyoCell SDF-1 (Stromal Derived Factor - 1) to treat congestive heart failure.

The REGEN trial will enroll 15 patients in a multicenter, randomized, dose escalation study to assess the safety and cardiovascular effects of the implantation of MyoCell SDF-1 in congestive heart failure patients post myocardial infarction(s). MyoCell SDF-1 is a composition of myogenic stem cells derived from a patient's own thigh muscle that has been modified to over express the SDF-1 protein. The product candidate is prepared with an 18-step proprietary method in a cGMP laboratory. Utilizing a cath lab procedure where a needle-tipped catheter is used to inject the cells into the scar tissue that has formed in the patient's heart.

The goal of MyoCell SDF-1 is to grow new contractile muscle within the scar tissue that will have the ability to release additional beneficial proteins to assist in the tissue repair process and improve the patient's heart function, exercise capacity and quality of life. In preclinical studies, MyoCell SDF-1 provided a 54 percent improvement of heart function compared to 27 percent for the original MyoCell composition, while the placebo control treated animals declined by 10 percent. The preclinical studies also demonstrated that this product candidate can enhance blood vessel formation in damaged hearts, the company said.

The U.S. trial is expected to begin this year. After completing the REGEN safety protocol with one-month follow-up, the company hopes to transition this second-generation product into its FDA-authorized Phase II/III MARVEL study. MyoCell SDF-1 is substantially similar to the original MyoCell composition that has been active in clinical trials since early 2001 at more than 50 centers worldwide.

The patents Bioheart has acquired covering the myogenic cells and SDF-1 compositions and methods are expected to provide intellectual property protection until 2023.

For more information: www.bioheartinc.com

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