FDA Lifts Clinical Hold on Pluristem's Phase II Intermittent Claudication Study
Pluristem Therapeutics Inc. (NSDQ: PSTI) announced today that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on the Company's U.S. Phase II Intermittent Claudication (IC) study (IND 15038) on June 4, 2013.
In its letter to Pluristem, the FDA indicated Pluristem had satisfactorily addressed all the clinical hold issues and the Company may proceed with the study.
Zami Aberman, Pluristem's Chairman and CEO commented, "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."