Pluristem Therapeutics, Inc. (PSTI) recently announced that the medical regulatory body for biological medicinal products in Germany, the Paul-Ehrlich-Institute (PEI), has approved the company’s request to conduct a phase II study using PLX-PAD cells in patients suffering from intermittent claudication (:IC).
Pluristem develops standardized cell therapy products from human placenta for the treatment of multiple disorders. The cells from placenta are derived using the company’s proprietary PluriX therapy and are known as PLacental eXpanded (PLX
) cells. IC is a subset of peripheral artery disease (:PAD).
The phase II study for IC will be a placebo-controlled trial wherein the safety and efficacy of two doses of PLX-PAD cells will be compared to placebo among 150 patients.
The key endpoint of the trial is the change in the maximal walking distance from baseline during an exercise treadmill test while secondary endpoints are hemodynamic and quality of life measurements.
According to The SAGE Group and HCUP 2007 Inpatient Data, approximately 14 million people in the US suffer from IC representing a cost of approximately $2.5 billion on an annual basis to the healthcare system.
Pluristem plans to open three clinical sites in Germany where the protocol will be same as the one used in the US where patient enrolment and dosing is in progress. Moreover, the company plans to open clinical sites in Israel, once regulatory approval is received.
We note that Pluristem develops and manufactures cell therapy products in collaboration with companies like United Therapeutics Corporation (UTHR
) or through research and clinical institutions.
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