PLURISTEM THERAPEUTICS INC. (NASDAQ:PSTI) Files An 8-K Other Events
Item 8.01. Other Events.
On October 7, 2020, Pluristem Therapeutics Inc. announced that the Israeli Ministry of Health has approved the commencement of patient enrollment in Israel for the registrant’s COVID-19 Phase II clinical trial under the protocol that was approved by the Paul Ehrlich Institute, 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 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 PLX PAD 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.
About PLURISTEM THERAPEUTICS INC. (NASDAQ:PSTI)
Pluristem Therapeutics Inc. is a developer of placenta-based cell therapy product candidates for the treatment of multiple ischemic, inflammatory and hematologic conditions. The Company’s lead indications are critical limb ischemia (CLI), recovery after surgery for femoral neck fracture and acute radiation syndrome. Its operations are focused on the research, development, clinical trials and manufacturing of cell therapeutics and related technologies. The Company’s products include PLX-PAD and PLX R18. The Company’s PLX cells are adherent stromal cells (ASCs) that are expanded using a three dimensional (3D) process. The system utilizes a synthetic scaffold to create an artificial 3D environment where placental-derived stromal cells can grow. The Company’s PLX products are administered using a standard needle and syringe. The Company’s PLX products are in clinical-stage development for multiple indications, such as cardiovascular, orthopedic, pulmonary and women’s health diseases.
