FDA lifts hold on Pluristem Therapeutics study

FDA lifts clinical hold on Pluristem Therapeutics study, allowing drug developer to proceed

Associated Press

The Food and Drug Administration has lifted a clinical hold it had placed in June on the study of a Pluristem Therapeutics Inc. stem cell therapy.

Pluristem said Monday it can proceed with its study after the FDA said it had addressed all the issues that led to the clinical hold. A brief statement from the Israeli company did not elaborate.

Pluristem said in June that the hold on the mid-stage study was caused by a patient who suffered a severe allergic reaction to treatment and was hospitalized. The company said a total of 74 patients have been treated in its studies and this was the first serious allergic reaction.

The drug developer said the patient had "multiple diseases" which may have made her allergic reaction worse. The patient was discharged from the hospital the next day, after all of her symptoms had cleared up.

Pluristem is studying a placenta-based stem cell therapy called PLX as a treatment for conditions including peripheral artery disease, or the narrowing of large arteries that supply blood to the extremities. The suspended trial aims to study the cells as a treatment for a symptom of peripheral artery disease called intermittent claudication, or pain in the calves following exercise.

U.S.-traded shares of Pluristem climbed more than 9 percent, or 30 cents, to $3.52 Monday about 2 ½ hours before the market opening. The stock had slipped 14 percent to close at $2.86 on June 4, the day the company announced the hold, but the shares have rallied since then.

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