FDA suspends Pluristem stem cell study

The US Food and Drug Administration (FDA) has suspended a Phase II clinical trial by Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) of its placental stem study for the treatment of intermittent claudication (calf muscle pain). The clinical hold was place after a patient suffered a serious allergic reaction which required hospitalization.

Pluristem said that this was the first serious allergic event among the 74 patients enrolled in the company's clinical trials to date. It added, "This event occurred in a patient with multiple diseases which may have influenced the severity of the event. The patient was discharged from the hospital the following day, following the resolution of all her symptoms."

The FDA will issue a letter within the next 30 days detailing a list of questions and requests for information from Pluristem. Pluristem chairman and CEO Zami Aberman said, "Once we receive the letter, we will work closely with the FDA to address all issues raised. We are committed to our strategy that our competitive technology advantage be involved in clinical programs for multiple indications."

Published by Globes [online], Israel business news - www.globes-online.com - on June 4, 2013