Business
Pluristem Announces Activation of Clinical Sites and Commencement of Patient Enrollment in U.S. FDA Phase II COVID-19 ARDS Trial
HAIFA, Israel, June 11, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a
About this update from Pluri Inc.
[{"type":"text","content":"HAIFA, Israel, June 11, 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 the activation of clinical sites and initiation of enrollment in its Phase II U.S. Food and Drug Administration (FDA) study of PLX cells for the treatment of severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS). The Company is focused on expanding to clinical sites throughout the U.S. in accordance with the changing dynamic spread of the COVID-19 pandemic, using its advanced operational capabilities and cold chain agility. The trial is expected to include up to 25 sites. \n The randomized, double-blind, placebo-controlled, multicenter, parallel-group 140 patient study is evaluating the efficacy and safety of intramuscular (IM) injections of PLX-PAD for the treatment of severe COVID-19 cases complicated by ARDS. The primary endpoint is the number of ventilator free days during the main 28-day study period. Safety and survival follow-up will be conducted at week 8, 26 and 52. Secondary efficacy endpoints include all-cause mortality, duration of mechanical ventilation, ICU free-days, and hospitalization free-days. “Pluristem is closely following the spread of the COVID-19 pandemic globally as well as the ‘hot spots’ in the U.S. We are targeting locations that show the highest rate of new cases and incorporating the ready-to-use advantages of our PLX-PAD product candidate. Pluristem’s confirmed operational and unique cold chain logistical capabilities enable us to treat patients within hours of notice. We also believe this will enable us to deliver COVID-19 treatments in a timely manner and in the right place, while assisting the healthcare systems in the fight against COVID-19, its complications, and its burden on the medical infrastructure.” PLX Cells for COVID-19 PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities, offering a key advantage in addressing a global pandemic. PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may prevent or reverse the dangerous overactivation of the immune system. Accordingly, PLX c...