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Sunrise, Fla., Biotech Company Develops Cell Therapy for Weak Hearts

Posted on: Sunday, 26 February 2006, 12:00 CST

By Glenn Singer, South Florida Sun-Sentinel

Feb. 24--Sunrise-based Bioheart Inc. has signed a patent-licensing agreement with The Cleveland Clinic in Ohio that company officials think will help them develop a second-generation cell therapy treatment for patients with weakened hearts.

Gaining the rights to five pending U.S. patent applications "gives us a piece of the puzzle we didn't have," said Howard Leonhardt, Bioheart's chief executive officer. Terms of the deal were not disclosed.

Bioheart focuses on cell therapy, a procedure in which healthy cells are injected into the heart to replace dead tissue that forms after a heart attack. Called MyoCell, the company's product is derived from immature skeletal muscle cells, called myoblasts, taken from the patient's thigh.

The procedure is in late-stage testing in Europe, and Leonhardt said this week that Bioheart could apply for commercial approval there before year's end. Testing in the United States has not progressed as far.

The Cleveland Clinic's patents cover a procedure, tested successfully in rats and pigs, that modifies muscle stem cell composition so that therapy can be more effective. In essence, cells injected into the heart are programmed to send out a homing signal to other stem cells in the body, telling them to come to the damaged site to help with recovery.

Cells naturally travel from other parts of the body to help a damaged heart, but that only lasts for a few days -- not enough time for sufficient healing, said Dr. Marc Penn from the departments of cardiovascular medicine and cell biology at The Cleveland Clinic.

"The technique we developed makes this happen for a couple to three weeks, and that produces a better recovery," Penn said.

He said his scientific group already had planned to meet with the Food and Drug Administration to discuss safety issues and the way to conduct a clinical trial in humans. With the Bioheart affiliation, that meeting might be pushed back until the collaborators have had time to formulate a strategy.

Typically, patent-rights deals can include royalties, payments for reaching certain development milestones and up-front payments. The pact between The Cleveland Clinic and Bioheart involved two of those, said Chris Coburn, executive director of CCF Innovations, the clinic's technology transfer and commercialization arm.

While it can take years for a patent to be issued, licensing pending patents gives a company the exclusive right to use the protected technology, he said.

"We chose Bioheart because the company has the ability to properly bring this innovation through all stages of clinical trials," Coburn said. "We also felt, for humanitarian reasons, Bioheart would be able to move this ahead rapidly. Dr. Penn really cares about bringing help to heart patients."

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Source: South Florida Sun-Sentinel

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