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Pluristem (PSTI) Gets FDA Approval for Phase I PLX-R18 Trial

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Investors in the pharma/biotech sector eagerly wait for pipeline updates as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight on the commercial potential of the candidate once it is successfully developed and commercialized.

Pluristem Therapeutics Inc. (PSTI - Free Report) announced that the FDA has cleared its Investigational New Drug (IND) application to begin a phase I trial on PLX-R18 cells for treating incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT).

The trial will begin in the first half of 2016. We note that PLX-R18 is Pluristem’s second cell therapy product to get be cleared by the FDA. The candidate has been studied for acute radiation syndrome, the support of HCT, and the side effects of radiotherapy and chemotherapies used to treat cancers in preclinical models.

The multi-center, open-label, dose-escalating study will evaluate the safety of intramuscular injections of PLX-R18 cells in subjects with incomplete hematopoietic recovery following HCT in three cohorts.

Pluristem is a company that focuses on the development of placenta-based cell therapy products. Its patented PLX (PLacental eXpanded) cells are being evaluated in multiple indications.

Last week, the FDA granted orphan drug designation to its placental-derived (PLX-PAD) cells for the treatment of severe preeclampsia. The company plans to initiate pivotal trials with PLX-PAD cells to obtain conditional marketing approval for the treatment of critical limb ischemia in Europe and Japan. Meanwhile, a phase II trial is currently ongoing on PLX-PAD cells for the treatment of intermittent claudication.

Pluristem carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics (ANIK - Free Report) , Gilead Sciences (GILD - Free Report) and Astrazeneca PLC (AZN - Free Report) . All three carry a Zacks Rank #1 (Strong Buy).

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