Author: Vitaliy Dadalyan

Pluristem Up 6% In Pre-Market On German Clearance For Covid-19 Study

Shares in Pluristem Therapeutics (PSTI) rose 6% in Monday’s pre-market trading after Germany’s health regulatory agency, the Paul Ehrlich Institute (PEI), approved Pluristem’s Phase II clinical protocol for its study of intramuscular injections of PLX PAD for the treatment of severe COVID-19.Forty 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 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...