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Message: Re: NEWS: FDA LIFTS CLINICAL HOLD ON PSTI TRIAL/ text

Thanks emma, here's the text (exciting news!!!):

FDA Lifts Clinical Hold of Pluristem's Phase II Intermittent Claudication Study

Press Release: Pluristem Therapeutics Inc.6 hours ago

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HAIFA, Israel, Sept. 16, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on the Company's U.S. Phase II Intermittent Claudication (IC) study (IND 15038) on June 4, 2013.

In its letter to Pluristem, the FDA indicated Pluristem had satisfactorily addressed all the clinical hold issues and the Company may proceed with the study.

Zami Aberman, Pluristem's Chairman and CEO commented, "Pluristem applauds the FDA's vigor to resolve this clinical hold as quickly as possible. We look forward to resuming this important study that addresses the growing, costly and potential serious indication of intermittent claudication."

About Pluristem's Phase II Intermittent Claudication (IC) Clinical Trial

Pluristem's Phase II Intermittent Claudication (IC) study uses the Company's PLX-PAD cells. Up to 150 patients will be enrolled in this dose escalation, randomized, double blind, multicenter, multinational, placebo-controlled trial whose primary endpoints at 12 months will be safety and maximal walking distance relative to baseline. The study protocol will be modified by tightening patient's eligibility criteria and by adding oral anti-histamines and a safety follow-up period for 24 hours post study treatment.

About Pluristem Therapeutics

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