Benzinga | Aug 10, 2020 07:02AM EDT

Pluristem Expands COVID-19 Program To Europe, Receives PEI Clearance To Commence Phase II Study In Germany

HAIFA, Israel, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that Germany's health regulatory agency, the Paul Ehrlich Institute (PEI), has cleared the Company's Phase II clinical protocol for its study titled, "A Randomized, Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of severe COVID-19." Forty (40) patients hospitalized with severe cases of COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) will be enrolled in the study.



The primary efficacy endpoint of the study is the number of ventilator free days during the 28 days from day 1 through day 28 of the study. Safety and survival follow-up will be conducted at day 60, week 26 and week 52.

"We are pleased to expand our COVID-19 program to an additional territory and look forward to commencing a clinical trial of our PLX cells for the treatment of severe COVID-19 cases complicated by ARDS in Europe. Based on our discussions with the PEI, this will be a standalone study, with the active arm compared to the current standard of care. Pluristem is conducting several advanced clinical development programs in Europe which are supported by the Horizon 2020 and, upon receipt of funds, by the European Investment Bank (EIB). We are grateful for their important support of our therapeutic platform. Pluristem is committed to utilizing what we believe is the major competitive advantages of our technological platform and to bringing regenerative medicine to patients in Europe and around the world," stated Pluristem CEO and President Yaky Yanay.

In addition to this study in Germany, Pluristem is currently conducting a Phase II COVID-19 trial in the U.S. which will enroll 140 patients.