HAIFA - Pluristem Therapeutics Inc.(Nasdaq: PSTI) (TASE: PSTI), a leading regenerative medicine company developing a platform for innovative biological therapeutics, today announced that the German health regulatory agency Paul Ehrlich Institute (PEI), approved the Company's Phase II clinical protocol for its 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 '(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 cases of COVID-19).

Forty (40) hospitalized patients with a severe form of COVID-19 accompanied by complications of acute respiratory distress syndrome (ARDS) will be enrolled in the study.

The main endpoint that will measure the effectiveness of the study is the number of days spent without a ventilator during the entire 28 days of the study. Monitoring the survival rate and the level of safety will be made at 60 th day and the 26 and 52 weeks.

'We are excited to expand our COVID-19 program to additional territory and look forward to starting the clinical trial of our PLX cells for the treatment of severe cases of COVID-19 and having developed complications of ARDS in Europe. Based on our discussions with the PEI, this will be an independent study, where the experimental group will be compared to the so-called control group according to standard treatment recommendations. Pluristem conducts several advanced clinical development programs in Europe which are supported by Horizon 2020 and, upon receipt of funds, by the European Investment Bank (EIB). We are grateful for their significant support to our therapy platform. Pluristem is committed to utilizing what we believe are the main competitive advantages of our technology platform and bringing regenerative medicines to patients in Europe and around the world, 'said Yaky Yanay, CEO and President of Pluristem.

In addition to this study in Germany, Pluristem is currently conducting a phase II trial on COVID-19 in the United States, which will enroll 140 patients.

PLX cells against COVID-19

PLX cells can be administered without a prescription and, once marketed, can be made in large quantities. Pluristem believes that its PLX cells will provide a key advantage in the fight against the global COVID-19 pandemic. PLX cells are similar to allogeneic mesenchymal cells; the immunomodulatory properties of these cells trigger the natural regulators of the immune system - M2 macrophages and T cells, and thus can prevent or reverse dangerous overactivation of the immune system. Therefore, PLX cells can potentially reduce the incidence and / or severity of pneumonia caused by COVID-19, hopefully leading to a better prognosis for patients.Results from previous preclinical studies with PLX cells have shown therapeutic benefits in animal studies for pulmonary hypertension, pulmonary fibrosis, acute kidney injury and gastrointestinal injury, which are potential complications of serious infections. to COVID-19. Clinical data on the use of PLX cells have demonstrated their great immunomodulatory power in patients who have undergone major surgery. Preliminary clinical data, obtained at the end of a 28-day follow-up in patients with COVID-19 in the intensive care unit and treated under a compassionate use program, have been previously published. The potential capacities of PLX cells,combined with the safety profile seen in clinical trials involving hundreds of patients around the world, place PLX cells as a potential treatment to mitigate the damaging effects of COVID-19 on tissue.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading regenerative medicine company developing innovative placenta-based cell therapy product candidates. The company has reported strong clinical trial data in several indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. The PLX cell product candidates are believed to release a variety of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematologic disorders and radiation damage. The cells are developed using technology fromthe company's proprietary three-dimensional expansion and can be administered to patients without requiring tissue compatibility. Pluristem has a strong intellectual property position: a company-owned and operated GMP certified manufacturing and research facility, strategic relationships with leading research institutions and a seasoned management team.

This notice contains forward-looking information within the meaning of the US Securities Act and the Safe Harbor provisions of the US Private Securities Litigation Reform Act of 1995.

Contact:

Dana Rubin

Tel: 972-74-7107194

Email: danar@pluristem.com

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