Pluristem Therapeutics Inc. (PSTI) recently received a major relief when the U.S. Food and Drug Administration (:FDA) lifted the clinical hold on its phase II intermittent claudication (:IC) study (IND 15038).
Shares of the company reacted positively to the news.
We note that the clinical hold was lifted after Pluristem addressed all issues raised by the FDA while placing the clinical hold.
We remind investors that on Jun 4, 2013, the company was informed that the FDA has placed a clinical hold on its phase II IC study following a serious allergic reaction in one of the patients who required subsequent hospitalization.
The patient was discharged the next day after the symptoms were managed.
Pluristem pointed out that the patient was suffering from multiple diseases which might have affected the severity of the allergic reaction.
Consequently, Pluristem provided the agency with additional information so as to speed up the review and resolution of the issues. The company also provided information from a database compiled from previous clinical studies.
We note that Pluristem develops placenta-based cell therapies in collaboration with companies like United Therapeutics (UTHR) or through research and clinical institutions.
The cells from placenta are derived using the company’s proprietary PluriX therapy and are known as PLacental eXpanded (PLX) cells. Pluristem’s first candidate in development, PLX-PAD, is intended to treat peripheral artery disease (:PAD).
With the clinical hold uplifted, Pluristem can now proceed with its phase II IC study which uses the proprietary PLX-PAD cells.
Meanwhile, Celgene Cellular Therapeutics, a wholly-owned subsidiary of Celgene Corp. (CELG), is also conducting research on stem cells derived from the human placenta and from the umbilical cord for the treatment of different diseases.
Pluristem carries a Zacks Rank #4 (Sell). Right now, Actelion Ltd. (ALIOF) looks attractive with a Zacks Rank #1 (Strong Buy).