HAIFA, Israel, December 27, 2021 (GLOBE NEWSWIRE) – Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI) (the “Company”), a leading biotechnology company, today announced the first results of its Phase II dose escalation studies evaluating the safety and efficacy of intramuscular injections of PLX-PAD cells for the treatment of acute respiratory distress syndrome (ARDS) associated with COVID-19. The analysis is based on 89 patients included in two phase II studies in the United States (the “United States study”) and in Europe and Israel (collectively, the “European study” and together with the United States study, the “Studies”).
The primary efficacy endpoint was the number of ventilator-free days (VFD) from day 1 to day 28 of the studies. VFD at day 60 and all-cause mortality at days 28 and 60 were secondary endpoints of efficacy in the studies. The studies did not meet the primary efficacy endpoint of statistically significant improvement in 28-day VFD. Based on the baseline risk factors of patients with ARDS, no difference in the safety profile was observed between PLX-PAD and placebo.
In July 2021, Pluristem announced its decision to bring the studies to an early clinical reading on the basis of 89 recruited patients, instead of the 180 patients initially planned (140 in the American study and 40 in the European study). The decision came in response to the evolution of COVID-19 as a disease and significant changes in the standard of care, leading to an increase in the severity of conditions for intubated patients. These changes in the course of COVID-19 raised major concern about the potential variability of the patient population in the studies. The early termination of recruitment resulted in a significant reduction in the statistical power of the studies.
The efficacy trends of the studies included:
- A single administration of 300 million PLX-PAD cells showed better results overall, compared to other treatment groups
- Patients in the US study treated with a single dose of 300 million PLX-PAD cells (n = 14) showed a 40% increased survival rate at day 60 compared to the placebo group (n = 14) (50 % vs. 35%)
- Patients in the EU study treated with a single dose of 300 million PLX-PAD cells (n = 11) showed a 27% increased survival rate at day 60 compared to the control group (n = 12 ) (64% vs. 50%)
- In the EU study, patients treated with a single dose of 300 million PLX-PAD cells experienced an increase in VFD on day 28 of 3.6 days, of 0.2 days in the control group (n = 12) at 3.8 days in the treated group (n = 11)
- In the EU study, patients treated with a single dose of 300 million PLX-PAD cells experienced an increase in VFD at day 60 of 112% or 6.6 days, from 5.9 days in the control group (n = 12) at 12.5 days in the treated group. (n = 11)
Pluristem CEO and Chairman Yaky Yanay said, “Pluristem has joined the global effort to tackle the evolving and unexpected COVID-19 pandemic. We have chosen to focus on the most severe intubated patients with ARDS associated with COVID-19, who have no viable treatment to date and who pose a challenge to healthcare systems around the world. With the upcoming new wave of the Omicron variant, we intend to explore the opportunities based on the efficiency trends obtained from the studies. I would like to thank everyone who was involved in the studies, including the patients and their families, our investigators and study staff, as well as the Pluristem team for putting in extraordinary efforts to conduct these important studies. during very difficult times.
About the studies:
The US study included 66 patients enrolled in a randomized, double-blind, placebo-controlled, multicenter, parallel group study with three treatment groups of PLX-PAD cells – single administration of 300 million cells, single administration of 600 million cells, or 300 million cells administered twice in a week’s interval; and two placebo control groups, single administration, and two administrations one week apart. All groups received study treatment in addition to the best standard medical care according to local practice.
The EU study enrolled 23 patients from Germany, Bulgaria and Israel in a randomized, controlled, multicenter, parallel group study with a single treatment arm (single dose of 300 million PLX-PAD cells) in plus the best standard medical care according to local practice, and a control group received the best standard medical care according to local practice.
Pluristem pushes the boundaries of science and engineering to reinvent pharmacological treatments and improve the quality of care. The Company’s cell therapies advance the field of regenerative medicine, with potentially revolutionary applications for the treatment of damaged muscles, hematologic impairments and inflammation. Pluristem derives its therapeutic cells from the placenta, a potent and ethically accepted source. The cells are easy to collect and do not require blood or tissue pairing. The cells of a placenta can potentially treat more than 20,000 patients. The company’s manufacturing platform is a state-of-the-art, patented and validated 3D cell expansion system designed to mimic the human body. The Pluristem method is particularly precise, cost effective and consistent from batch to batch.
Safe Harbor Declaration
This press release contains forward-looking statements, express or implied, under the Private Securities Litigation Reform Act of 1995 and other United States federal securities laws. For example, Pluristem uses forward-looking statements when discussing the intention to explore opportunities based on data obtained from studies. These forward-looking statements and their implications are based on the current expectations of Pluristem’s management 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 forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in the launch and / or success of its clinical trials; Pluristem’s products may not be approved by regulatory bodies, Pluristem’s technology may not be validated as it progresses, and its methods may not be accepted by the scientific community; Pluristem may not be able to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with the Pluristem process; Pluristem’s products may end up being more expensive than expected; laboratory results may not translate to such good results in actual clinical settings; the results of preclinical studies may not correlate with the results of clinical trials in humans; Pluristem’s patents may not be enough; Pluristem’s products may harm recipients; changes in legislation may have a negative impact on Pluristem; the inability to develop and introduce new technologies, products and applications in a timely manner; loss of market share and price pressure resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in these forward-looking statements. Unless otherwise required by law, Pluristem does not undertake to publish revisions of these forward-looking statements to reflect events or circumstances subsequent to the date hereof or to reflect the occurrence of unforeseen events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Director of Investor Relations