Benzinga | Jul 8, 2021 07:14AM EDT

Pluristem Says Is Bringing 'ARDS Associated with COVID-19 Phase II Studies' To Clinical Readout; Topline Results Expected During Q4

* The company will analyze data based on patients enrolled to date in COVID-19 Phase II studies in U.S., Europe and Israel

* Topline results are expected during the fourth quarter of 2021

HAIFA, Israel, July 08, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI) (the "Company"), a leading biotechnology company announced today that it is bringing its Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 Phase II studies to clinical readout. The Company's COVID-19 program included over 100 patients across two Phase II studies in the U.S., Europe and Israel, and in compassionate use and expanded access programs in the U.S. and Israel. The analysis will be based on 89 patients enrolled in the previously announced two Phase II studies, which investigated the safety and efficacy of Pluristem's PLX cells as a treatment for severe COVID-19 cases complicated by ARDS.

This decision comes in response to COVID-19's evolution as a disease, as well as changes in the standard of care and a decline in the most severe cases. For the same reason, the Company will not pursue plans announced in December 2020 to expand Pluristem's COVID-19 program to Mexico in collaboration with Innovare R&D. Pluristem expects to announce the topline results of the readout during the fourth quarter of 2021.

As part of the clinical readout, Pluristem will examine the safety and efficacy of PLX cells for treating ARDS, a condition associated with a number of illnesses in addition to COVID-19 including sepsis, smoke and toxic chemical inhalation, head and chest injuries, and pancreatitis. ARDS continues to pose a significant clinical challenge that affects over 200,000 Americans annually, roughly 10 percent of Intensive Care Unit patients and 23 percent of ventilated patients worldwide.

Pluristem continues to advance its product candidate pipeline -- PLX-PAD and PLX-R18 -- on a number of fronts. Pluristem's PLX-PAD treatment exhibits the potential to stimulate tissue regeneration in response to muscle trauma and inflammation. PLX-PAD is currently in a Phase III multinational clinical trial testing the safety and efficacy of accelerating muscle regeneration following HIP fracture surgery. Additionally, Pluristem recently reported positive Phase I topline results from its evaluation of PLX-R18 cells to address incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT). The Company's unique proprietary process and advanced development and manufacturing capabilities enable it to produce PLX cells at significant scale.