PLURISTEM THERAPEUTICS INC. (NASDAQ:PSTI) Files An 8-K Other Events
Item 8.01. Other Events.
On June 11, 2020, Pluristem Therapeutics Inc., or the registrant, announced 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) and that the trial is expected to include up to 25 sites. The registrant stated that it 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. 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.
Warning Concerning Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are being used when the registrant discusses its focus on expanding clinical sites throughout the U.S. and the expected number of clinical sites it expects will be included in the trial. These forward-looking statements and their implications are based on the current expectations of the management of the registrant only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; the registrant may encounter delays or obstacles in launching and/or successfully completing its clinical trials; the registrant’s products may not be approved by regulatory agencies, the registrant’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; the registrant may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; the registrant’s products may wind up being more expensive than the registrant anticipates; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; the registrant’s patents may not be sufficient; the registrant’s products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of the registrant to differ materially from those contemplated in such forward-looking statements. In addition, historic results of scientific research do not guarantee that the conclusions of future research would not suggest different conclusions or that historic results would not be interpreted differently in light of additional research or otherwise. Except as otherwise required by law, the registrant undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting the registrant, reference is made to the registrant’s reports filed from time to time with the Securities and Exchange Commission.
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.