Pluristem Therapeutics Inc. (PSTI - Free Report) received positive news when the Israeli Ministry of Health approved its request to initiate a phase II study using its PLacental eXpanded (PLX) cells for the intermittent claudication (IC) indication.
IC is a subset of peripheral artery disease (PAD). Pluristem develops placenta-based cell therapies. The cells from placenta are derived using the company’s proprietary PluriX therapy and are known as PLX cells.
The phase II IC study will evaluate the efficacy of two doses of PLX-PAD cells compared to placebo, administered via intramuscular injections. The primary end point of the trial is the change in the maximal walking distance from baseline during an exercise treadmill test while secondary endpoints include hemodynamic and quality of life measurements.
The protocol will be the same as the one used in the U.S study.
Last month, Pluristem received a major relief when the U.S. Food and Drug Administration (FDA) lifted the clinical hold on its phase II IC study. 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 the FDA placed a clinical hold on the company’s phase II IC study in Jun 2013 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.
We note that Pluristem develops placenta-based cell therapies in collaboration with companies like United Therapeutics (UTHR - Free Report) or through research and clinical institutions.
Pluristem carries a Zacks Rank #4 (Sell). Right now, Actelion Ltd. and Athersys, Inc. (ATHX - Free Report) look attractive. While Actelion carries a Zacks Rank #1 (Strong Buy), Athersys carries a Zacks Rank #2 (Buy).