Bioheart Announces Plans to Launch Clinical Trials in Europe and the USA for Second-generation Cell Therapy for Treating Advanced Heart Failure
Four Years of Sponsored Animal Studies At Cleveland Clinic and the University of Florida Have Demonstrated That Second-generation Cell Therapy, MyoCell(r) SDF-1, Provides Double the Level of Improvement as the First-generation MyoCell(r) Composition
SUNRISE, Fla., Jan. 13, 2009 (GLOBE NEWSWIRE) -- Bioheart, Inc. (Nasdaq:BHRT) announced today that it plans to conduct clinical trials for its second-generation MyoCell SDF-1 myogenic cell composition for treating advanced heart failure. The company believes that it may be able to fund these trials to a large extent with grant funding, which will be non-dilutive to the company's investors. Earlier this year, Bioheart approached the National Heart, Lung and Blood Institute of the National Institutes of Health to discuss the possibility of their Cardiovascular Cell Therapy Research Network Centers to participate in these new clinical trials.
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 Bioheart's cGMP laboratories. Utilizing a needle-tipped catheter inserted into the groin of a patient who is suffering from heart failure, the cells are injected 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 animal 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 company filed an IND application with the FDA last year and is near completing the additional studies suggested by the FDA to move the MyoCell SDF-1 into clinical trials in the USA. The U.S. trial is expected to begin this year. After completing a 15-patient dose escalation safety protocol study with one-month follow-up, the company hopes to transition this second-generation product into its FDA-authorized Phase II/III MARVEL study, currently active at 35 centers in the USA. 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 company has also begun the appropriate regulatory filings to initiate MyoCell SDF-1 clinical studies in Europe and other foreign countries. This quarter, the company has filed or will be filing in Switzerland, the Netherlands, Italy, Belgium, Singapore, Brazil and Korea.
Bioheart expects a new state-of-the-art cGMP cell culture facility in Seoul, Korea, with capacity to culture more than 1,800 patients a month, to be up and running in 1Q 2009. This facility, 18% owned by Bioheart, was designed by NNE Pharmaplan, Denmark, is heralded as the most advanced cell culture and biologics manufacturing operation in the world. This facility will be additive to Bioheart's cGMP facility at its headquarters in Sunrise, Florida, and to the contract facility in Maastricht, the Netherlands, which Bioheart has engaged with Pharmacell.
"All the data gathered over many years supports moving the MyoCell SDF-1 composition to clinical trials at this time to serve advanced heart failure patients who are facing worse than 50 percent risk of death within three years," said Dr. Marc Penn, Medtronic Bakken Chair of Research, Cleveland Clinic. "These patients desperately need something better, and this composition has a chance to be it."
"Bioheart is committed to continuous improvement of our products and services," said Howard J. Leonhardt, chairman, CEO and CTO of Bioheart. "Years of work by many team members have led to this milestone development. We believe, more so than ever before, that we represent the best hope for the more than 25 million people suffering of heart failure 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.
About Bioheart, Inc.
Bioheart, Inc. (Nasdaq:BHRT) is committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases. Its goals are 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. Its lead product candidate, MyoCell(r), is an innovative clinical muscle-derived stem 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. The Company's pipeline includes multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose tissue-derived stem cell treatment for acute heart damage, and MyoCell SDF-1, a therapy utilizing autologous cells that are genetically modified to express additional potentially therapeutic growth proteins. For more information on Bioheart, visit www.bioheartinc.com.
MyoCell and MyoCell SDF-1 are trademarks of Bioheart, Inc.
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