US FDA lifts clinical hold on Pluristem's Phase II study

Israeli biotech company Pluristem Therapeutics (TASE: PLTR/NASDAQCM: PSTI) says the US Food and Drug Administration has lifted the clinical hold previously placed on the company’s US Phase II intermittent claudication (IC) study (The Pharma Letter June 5).

In its letter to Pluristem, a leading developer of placenta-based cell therapies, the FDA indicated the company had satisfactorily addressed all the clinical hold issues and the company may proceed with the study. The clinical hold has been imposed due to a serious allergic reaction in a case which required hospitalization.

Zami Aberman, Pluristem’s chairman and chief executive, 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.”