FDA Covid-19 trial nod boosts Pluristem

Yaky Yanay Photo: Einat Levron

The FDA has cleared Pluristem's application for a Phase II study of its PLX cells in the treatment of severe Covid-19 cases.

Pluristem Therapeutics Inc. (Nasdaq:PSTI; TASE: PSTI) announced on Thursday that the US Food and Drug Administration (FDA) had cleared the company’s Investigational New Drug (IND) application for a Phase II study of its PLX cells in the treatment of severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome (ARDS).

Pluristem's share price rose 16.49% in New York on Thursday in response to the announcement, giving the company a market cap of $177 million. On the Tel Aviv Stock Exchange this morning, the share price is up 11.77%, at NIS 34.00.

The study, titled "A Randomized, Double-Blind, Placebo-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" will treat 140 adult patients that are intubated and mechanically ventilated and are suffering from respiratory failure and ARDS due to COVID-19. The primary efficacy endpoint of the study is the number of ventilator free days during the 28 days from day 1 through day 28 of the study.

Pluristem has been treating patients suffering from severe complications caused by COVID-19, such as ARDS and inflammatory complications, in the US and Israel through compassionate use programs. Preliminary data from these compassionate use programs in Israel were reported on April 7, 2020. A Clinical Trial Authorization (CTA) has also been filed in Europe for a Phase II COVID-19 trial, with the first European clinical sites planned in Germany and Italy.

Pluristem CEO and president Yaky Yanay said, "We are shifting gears now with a main focus on a rapid initiation of the clinical trial, leveraging our technological and logistical competitive advantages developed through our clinical trial experience in the US and Europe. We believe we can complete enrollment quickly and we expect to provide guidelines on the expected study duration a few weeks following the commencement of the study. We look forward to working with hospitals and physicians on a larger scale to deliver our PLX cells, through an off-the-shelf, easy to use PLX cell product candidate, which may potentially accelerate recovery time from life threatening conditions, and to improve survival, in the most severe COVID-19 cases."

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 prevent or reverse the dangerous overactivation of the immune system. Accordingly, PLX cells may potentially reduce the incidence and/or severity of COVID-19 pneumonia and pneumonitis leading hopefully to a better prognosis for the patients, Pluristem said in its announcement.

Published by Globes, Israel business news - en.globes.co.il - on May 10, 2020

© Copyright of Globes Publisher Itonut (1983) Ltd. 2020

Yaky Yanay Photo: Einat Levron
Yaky Yanay Photo: Einat Levron
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