Pluristem: FDA Clears IND Application For Phase II COVID-19 Study

(RTTNews) - Pluristem Therapeutics Inc. (PSTI), an Israeli regenerative medicine company, announced Friday that the U.S. Food and Drug Administration has cleared its Investigational New Drug or 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 or ARDS.

The objective of the study is to evaluate the efficacy and safety of one or two intramuscular injections, in three different dosages, of PLX-PAD for the treatment of ARDS resulting from COVID-19.

The study 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. The primary endpoint determination will be performed at the end of the 28 day main study period.

Pluristem said it has been treating patients suffering from severe complications caused by COVID-19, such as ARDS and inflammatory complications, in the U.S. and Israel through compassionate use programs.

A Clinical Trial Authorization has also been filed in Europe for a Phase II COVID-19 trial, with the first European clinical sites planned in Germany and Italy.