Pluristem to develop stem cell therapy on its own

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BANGALORE | Mar 23, 2011
(Reuters) - Israel's Pluristem Therapeutics Inc (PSTI.O) (PSTI.TA) said it will go solo in developing its stem cell therapy to treat severe obstruction of arteries that can lead to amputation, but will look for a marketing partner to launch the therapy.

"We do not need to raise money and we have sufficient capital to move the company to the end of Phase III studies," Chief Executive Zami Aberman told Reuters.

Pluristem, which raised about $38 million in a public offering last month, plans to start a Phase II/III trial in both Europe and the United States to treat critical limb ischemia (CLI) in the second half of the year.

The disease afflicts about 1 million Americans and results in 160,000 amputations each year.

And there are currently no drugs approved by the U.S. Food and Drug Administration (FDA) for CLI. Experimental medicines of companies including Vical Inc (VICL.O) and Sanofi-Aventis (SASY.PA) had failed late-stage trials.

Aberman said the company would complete the development of the therapy on its own and expects to sign a marketing deal before completing late-stage trials.

"We have been approached by a variety of pharmaceutical companies interested in cooperating not only on CLI but (also) for additional indications like inflammatory bowel disease, multiple sclerosis and orthopedic indication," he said.

The company's allogeneic approach used in processing stem cells from donors' placenta enables the development of off-the-shelf, or ready to use treatment for CLI patients.

"The fact that we can do the treatment on demand because we have an off-the-shelf product is crucial, since CLI patients require immediate treatment," Aberman said.

Rival Aastrom Biosciences (ASTM.O), which is currently leading the race to develop a CLI treatment, favors autologous therapy to process stem cells from a patient's bone marrow.

(Reporting by Anand Basu in Bangalore; Editing by Gopakumar Warrier)