HAIFA - Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), a leading regenerative medicine company developing a platform of new therapeutic biologics, announced today that Germany's health regulatory agency, the 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 forms of COVID-19.

'Forty (40) patients hospitalized with severe forms of COVID-19 who present with acute respiratory distress syndrome (ARDS) will be recruited into the study.

The primary efficacy endpoint of the study is to establish the number of ventilator-free days during the 28 post-enrollment days, days 1 to 28 of the study. Follow-up will focus on treatment safety and survival and is scheduled for day 60 and weeks 26 and 52 post enrollment.

'We are delighted to expand our COVID-19 program to another territory and are thrilled to be able to begin a clinical trial of our PLX cells for the treatment of severe cases of COVID-19 complicated by ARDS in Europe. Based on our discussions with the IEP, this will be an independent study, with the active arm compared with the current standard of care. Pluristem is conducting several advanced clinical development programs in Europe, supported by both Horizon 2020 and funds from the European Investment Bank (EIB) We are grateful for their important support to our therapy platform.Pluristem is committed to using what we believe to be the main competitive advantages of our technology platform and bringing regenerative medicine to patients in Europe and around the world, 'said Pluristem CEO and President, Yaky Yanay.

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

Contact:

Dana Rubin Investor

Tel: 972-74-7107194

Email: danar@pluristem.com

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