Monday, September 16, 2013

Reuters: Regulatory News: Pluristem says FDA lifts hold on muscle pain drug study

Reuters: Regulatory News
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Pluristem says FDA lifts hold on muscle pain drug study
Sep 16th 2013, 11:03

Sept 16 | Mon Sep 16, 2013 7:03am EDT

Sept 16 (Reuters) - Pluristem Therapeutics Inc said the U.S. Food and Drug Administration lifted its clinical hold on a mid-stage trial of the company's experimental drug for muscle pain.

The company's shares rose 9 percent to $3.52 in premarket trading.

The Israel-based company said the FDA allowed it to go ahead with the study, saying that Pluristem had addressed all issues related to the hold.

The FDA put the study on hold in June after a patient in the study was hospitalized due to a serious allergic reaction.

The company suspended trials in the United States and Europe.

The drug, codenamed IND 15038, is designed to treat intermittent claudication, or pain caused by reduced blood flow to the muscles of the leg during exercise.

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