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Biotech / Medical : Pluristem Therapeutics
PSTI 8.720+0.2%Aug 14 5:00 PM EST
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From: xcentral16/16/2009 10:05:05 AM
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Pluristem Therapeutics Inc granted European regulatory approval for placental-derived stem cell clinical trial

Jun 16, 2009 (M2 EQUITYBITES via COMTEX) -- Pluristem Therapeutics Inc (NasdaqCM:PSTI) (DAX:PJT), a bio-therapeutics company, said on Tuesday that Germany's Paul Ehrlich Institute has granted approval of the company's Clinical Trial Application (CTA).
The company can now commence clinical trials with its placental-derived adherent stromal cell product, PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

In addition Pluristem has received approval from the Ethics Committee and clearance from the US Food & Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a similar trial in the United States.

These approvals of the CTA and IND clear the way for the world's "first-in-man" clinical trial using PLX-PAD, Pluristem said.

The US and European trials will enrol patients diagnosed with CLI who are facing amputation.

According to the company, PLX-PAD is an off-the-shelf, one-size-fits-all product that needs no tissue matching prior to being administered to patients. In these Phase I trials, to be conducted at multiple locations in the US and Germany, PLX-PAD will be administered to patients considered "late stage" that have not responded to traditional medical or surgical interventions.

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