Pluristem Therapeutics Inc. (PSTI) recently announced that it has provided the US Food and Drug Administration (:FDA) with additional information regarding the clinical trials for intermittent claudication (:IC) pursuant to a clinical hold on the phase II IC study earlier this month.
We remind investors that on Jun 4, 2013, the company was informed that the FDA has placed a clinical hold on a 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.
Although the 30-day period within which the FDA is expected to provide a letter to the company containing a list of questions and information required is yet to expire, Pluristem has already provided the agency with additional information so as to speed up the review and resolution of the issues. The company provided information from a database compiled from previous clinical studies.
Meanwhile, as the study is being conducted both in the US and Germany, Pluristem informed the Paul-Ehrlich-Institute (PEI) in Germany about the clinical hold by the FDA and provided relevant information. Consequently, the IC study in Germany has also been put on hold.
Pluristem develops placenta-based cell therapies and currently does not have any approved product/therapy. Hence, a hold on the mid-stage trial in the US and Germany is a major setback for the company.
We expect investor focus in the near term to remain on further updates on the clinical hold.
Celgene Cellular Therapeutics, a wholly-owned subsidiary of Celgene Corporation (CELG), is also conducting research on stem cells derived from the human placenta as well as from the umbilical cord for the treatment of different diseases.
Pluristem carries a Zacks Rank #4 (Sell). Right now, Biogen Idec, Inc. (BIIB) and Aeterna Zentaris, Inc. (AEZS) look attractive. While Biogen Idec carries a Zacks Rank #1 (Strong Buy), Aeterna Zentaris carries a Zacks Rank #2 (Buy).
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