FDA lets Pluristem continue Phase 2 trial

The FDA has lifted the clinical hold on the company's US Phase 2 clinical trial of its placental stem cells for the treatment of intermittent claudication.

Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) has obtained a green light to continue a Phase 2 clinical trial of its stem cell product, after the US Food and Drug Administration (FDA) lifted the clinical hold on the company's US Phase 2 intermittent claudication study placed on June 4, 2013.

Pluristem's share price rose 8.3% in morning trading on the TASE today to NIS 12.55, and rose 5% in premarket trading on Nasdaq to $3.88, giving a market cap of $200 million.

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

Pluristem's Phase 2 intermittent claudication study uses its PLX-PAD placental stem cells. Up to 150 patients will be enrolled in the trial. 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.

Pluristem chairman and CEO Zami Aberman said, "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."

Published by Globes [online], Israel business news - www.globes-online.com - on September 16, 2013

© Copyright of Globes Publisher Itonut (1983) Ltd. 2013

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