Pluristem PSTI Stock News

Pluristem Therapeutics Inc. (NASDAQ: PSTI) is running for the top in the market after the company announced that the United States FDA has cleared the company’s IND for a potential COVID-19 treatment. The stock is up nearly 20% as a result. Here’s what’s happening:

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PSTI Stock Flies On COVID-19 IND Clearance

In the release, Pluristem Therapeutics said that the FDA has cleared its Investigational New Drug application for a Phase II study of its PLX cells. These PLX cells will be assessed as a potential treatment for severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome.

The company said that the study will be a  Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group study. The aim is to evaluate the efficacy and safety of intramuscular injections of PLX-PAD for the treatment of severe COVID-19 patients.

Through the study PSTI will treat 140 adult patients that are intubated and mechanically ventilated and are suffering from respiratory failure and ARDS due to COVID-19. The company said that the primary efficacy endpoint of the study is the number of ventilator free days during a 28 day period.

In a statement, Yaky Yanay, President and CEO at PSTI, had the following to offer:

We are very pleased to gain clearance to commence our Phase II COVID-19 study in the U.S. 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 U.S. 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.

In the last few weeks, we have received dozens of applications from physicians and families seeking to participate in the Expanded Access per patient program. 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.

This News Is Huge

I don’t have to tell you how serious COVID-19 is. Chances are that you life has changed quite a bit since the pandemic started. Of course, to get the pandemic under control, we need vaccines and treatment options, that’s where the news from Pluristem Therapeutics comes in.

The company’s PLX-PAD treatment is likely to be effective in the treatment of COVID-19 patients with the most severe symptoms. Today’s IND clearance gives the company the opportunity to prove that this treatment can be effective.

Should PSTI prove that PLX-PAD injections can reduce time on vetillators for the most sick COVID-19 patients, the drug will likely prove to be overwhelmingly valuable. As such, this is a stock that’s well worth paying attention to.

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