Israel-based Pluristem Therapeutics Inc. (PSTI) recently reported progress on its phase I/II clinical trial, which is evaluating the safety and efficacy of its PLacental eXpanded (PLX) cells in the treatment of muscle injury.
Pluristem develops placenta-based cell therapies. The cells from placenta are derived using the company’s proprietary PluriX therapy.
Safety is the primary endpoint of the study while the secondary endpoint is the gluteal muscle function after six months.
A positive outcome from this study will enable Pluristem to further evaluate the potential of PLX cells for this indication along with other non-surgical injuries such as sports injuries.
Pluristem develops and manufactures cell therapy products in collaboration with companies like United Therapeutics or through research and clinical institutions.
Pluristem intends to develop and produce cell therapy products for the treatment of multiple disorders using several methods of administration.
We note that Pluristem and its partner United Therapeutics (UTHR) entered into a licensing agreement in Jun 2011 as per which United Therapeutics develops, markets and sells Pluristem's PLX cells for pulmonary arterial hypertension (PAH).
Both the companies commenced a phase I study in Australia using Pluristem's PLX cells following favorable preclinical studies in Feb 2013.
In a significant development in Feb 2013, the US Food and Drug Administration (FDA) granted Pluristem's PLX cells an orphan drug status for the treatment of aplastic anemia.
Meanwhile, Celgene Corporation (CELG) is also carrying out 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 #3 (Hold). Pharma stocks, such as Array Biopharma (ARRY) currently appear to be attractive with a Zacks Rank #2 (Buy).
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