Pluristem wins FDA-EMEA approval for stem cell trials

The company will conduct a Phase II/III study of its product on blocked arteries, and a Phase II study on ischemia colitis.

Pluristem Therapeutics Ltd. (Nasdaq:PSTI; TASE: PLTR; DAX: PJT) has successfully completed a parallel scientific advisory process with the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) for the planned clinical development program for its placenta-derived cell therapy, PLX-PAD, for blocked arteries in the limbs and heart.

The company said that it is now in a position to advance towards two clinical studies with its PLX-PAD cells: a joint FDA-EMEA Phase II/III study for critical limb ischemia (CLI) or severe blockage in the arteries; and a Phase II study for ischemia colitis (IC), or inflammation and injury of the large intestine result from inadequate blood supply, This study will be under the FDA and Germany's Paul Ehrlich Institute (PEI), which is the responsible authority in the EU.

Pluristem's placental cells do not cause rejection by either the mother's body or the fetus, and the company says that they cause little rejection when injected into another person's body. This minor reaction is in contrast to bone marrow derived stem cells, which have to be customized to the patient to prevent an immune reaction.

Pluristem chairman and CEO Zami Aberman said, “PLX-PAD has shown promise throughout its initial clinical development, and I am pleased that both the EMA and FDA have acknowledged our proposed comprehensive clinical development plan, which may lead to an advanced cell therapy product that could help millions of PAD patients."

He added, "The completion of two Phase-I CLI clinical studies, performed in parallel in Germany and the US, placed Pluristem in a unique position to discuss with the regulatory agencies an approach that should allow a single clinical study protocol to be accepted by both agencies.

“What is particularly exciting about this development is that it places us, for the first time, on track for a potentially preventative treatment for PAD in addition to treating amputation-destined cases."

Pluristem's share price rose 9.7% on TASE before trading was suspended, but fell back to a gain of 3.2% by the end of the session. The share rose 15.8% at the opening on Nasdaq to $3.15, after soared 29% in premarket trading, giving a market cap of $81 million.

Published by Globes [online], Israel business news - - on January 18, 2011

© Copyright of Globes Publisher Itonut (1983) Ltd. 2011

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