SPY342.73-0.65 -0.19%
DIA281.97-0.98 -0.35%
IXIC11,484.69-31.80 -0.28%

Pluristem Announced Approval to Expand its Phase II COVID-19 European Clinical Trial to Israel

Pluristem Therapeutics Inc. (Nasdaq: PSTI) announced today that it has received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for the Company's COVID-19 Phase II clinical trial, under the protocol that was approved by the Paul Ehrlich Institute (PEI), Germany's regulatory agency.

· 10/07/2020 05:23
Pluristem Therapeutics Inc. (NASDAQ:PSTI) announced today that it has received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for the Company's COVID-19 Phase II clinical trial, under the protocol that was approved by the Paul Ehrlich Institute (PEI), Germany's regulatory agency. A total of 40 patients hospitalized with severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) will be enrolled at clinical sites in Israel and Germany. The Phase II COVID-19 European clinical trial that is being expanded to Israel is in addition to Pluristem's other COVID-19 clinical programs, including a Phase II study and an Expanded Access Program in the U.S., both under the U.S. Food and Drug Administration's (FDA) approved protocol, and a per-patient compassionate use program in Israel. The primary efficacy endpoint of the Phase II European study titled, "A Randomized, Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLXPAD for the Treatment of severe COVID-19" is the number of ventilator free days during the 28 days from day 1 through to day 28 of the study. Safety and survival follow-up will be conducted up to week 52. "We believe that the approval from the Israeli Ministry of Health will enable us to advance the treatment of severe COVID-19 patients. As the pandemic continues in Israel, we see it as our mission to treat those severe patients in need. With our broad COVID-19 clinical programs in Europe and the U.S., we are committed to advancing our research and developing a treatment that may help save lives," stated Pluristem CEO and President Yaky Yanay.