Pluristem Therapeutics Inc (PSTI)

[midastouch017]

Pluristem on go in Germany to start late-stage study of PLX-PAD cells to treat CLI; shares off 1% premarket

Jan. 17, 2017 7:19 AM ET|About: Pluristem Therapeutics... (PSTI)|By: Douglas W. House, SA News Editor
Germany's health regulator the Paul Ehrlich Institute has cleared Pluristem Therapeutics (NASDAQ:PSTI) to commence enrollment in a Phase 3 study assessing PLX-PAD cells to treat Critical Limb Ischemia (CLI), a painful condition of the hands, legs and feet caused by severe obstruction of the arteries which profoundly reduces blood flow to the extremities. The U.S. FDA and the UK's Medicines & Healthcare products Regulatory Agency (MHRA) are also on board.

According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is February 2020.

PLX-PAD for the treatment of CLI is in Europe's Adaptive Pathways pilot project which provides for early marketing approval based on successful interim results from the first 125 patients that have completed 12 months of follow-up. Data from the entire 250-subject group will be used to support a Biologics License Application (BLA) in the U.S. and an application for full marketing approval in the EU.

Germany is Europe's largest CLI market.

PLX cells are mesenchymal-like adherent stromal cells derived from full term human placentas that may be administered without the need for HLA matching. According to the company, PLX-PAD (peripheral artery disease) cells have demonstrated the ability to stimulate the growth of new blood vessels in preclinical models inducing muscle tissue regeneration and improving muscle function.