Pluristem Expands its Phase II COVID-19 European Clinical Trial to Israel

Pluristem Therapeutics announced it has received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for the Company’s COVID-19 Phase II clinical trial, under the protocol that was approved by the Paul Ehrlich Institute (PEI), Germany’s regulatory agency. A total of 40 patients hospitalized with severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) will be enrolled at clinical sites in Israel and Germany.

The Phase II COVID-19 European clinical trial that is being expanded to Israel is in addition to Pluristem’s other COVID-19 clinical programs, including a Phase II study and an Expanded Access Program in the U.S., both under the U.S. Food and Drug Administration’s (FDA) approved protocol, and a per-patient compassionate use program in Israel.

The primary efficacy endpoint of the Phase II European study titled, “A Randomized, Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLXPAD for the Treatment of severe COVID-19” is the number of ventilator free days during the 28 days from day 1 through to day 28 of the study. Safety and survival follow-up will be conducted up to week 52.

Yaky Yanay CEO and President Pluristem Said: “We believe that the approval from the Israeli Ministry of Health will enable us to advance the treatment of severe COVID-19 patients. As the pandemic continues in Israel, we see it as our mission to treat those severe patients in need. With our broad COVID-19 clinical programs in Europe and the U.S., we are committed to advancing our research and developing a treatment that may help save lives”

PLX Cells for COVID-19

PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities, which we believe offers a key advantage in addressing a global pandemic. PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may potentially reverse the dangerous overactivation of the immune system. Accordingly, PLX cells may potentially reduce the severity of COVID-19 pneumonia, leading hopefully to a better prognosis for the patients. Previous pre-clinical findings of PLX cells revealed therapeutic benefit in animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury which are potential complications of the severe COVID-19 infection. Clinical data using PLX cells demonstrated the strong immunomodulatory potency of PLX cells in patients post major surgery. Initial clinical data on COVID-19 ICU patients, treated under a Compassionate Use Program, at the conclusion of a 28 day follow up were previously published. Taken together, PLX cells’ potential capabilities with the safety profile observed from clinical trials involving hundreds of patients worldwide potentially position them as a therapy for mitigating the tissue-damaging effects of COVID-19.

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