Shares in Pluristem Therapeutics (PSTI) rose 6% in Monday’s pre-market trading after Germany’s health regulatory agency, the Paul Ehrlich Institute (PEI), approved Pluristem’s Phase II clinical protocol for its study of intramuscular injections of PLX PAD for the treatment of severe COVID-19.
Forty patients hospitalized with severe cases of COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) will be enrolled in the study.
The primary efficacy endpoint is the number of ventilator free days during the 28 days from day 1 through day 28 of the study. Safety and survival follow-up will be conducted at day 60, week 26 and week 52.
“We are pleased to expand our COVID-19 program to an additional territory and look forward to commencing a clinical trial of our PLX cells for the treatment of severe COVID-19 cases complicated by ARDS in Europe. Based on our discussions with the PEI, this will be a standalone study, with the active arm compared to the current standard of care” stated Pluristem CEO Yaky Yanay.
In addition to this study in Germany, Pluristem is currently conducting a Phase II COVID-19 trial in the U.S. which will enroll 140 patients.
The company believes its PLX cells will offer a key advantage in addressing the COVID-19 global pandemic. PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities. The cells have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and as a result may potentially reduce the incidence and/or severity of COVID-19 pneumonia.
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.
Initial clinical data at the conclusion of a 28 day follow up from COVID-19 ICU patients that were treated under a Compassionate Use Program, were previously published. Following these results, Maxim Group’s Jason McCarthy reiterated his buy rating with a $12 price target.
“A key driver of mortality in COVID-19 is the uncontrolled inflammatory response that occurs in the lungs upon viral infiltration, known as acute respiratory distress syndrome (ARDS). PLX cells have demonstrated early signals of efficacy (and continued safety) in COVID-19 ARDS patients” he commented. “It seems to us that regenerative medicine is moving closer to having its day” the analyst concluded. (See Pluristem stock analysis on TipRanks).
Overall the stock scores a Strong Buy analyst consensus while the $14.50 average analyst price target indicates over 60% upside potential lies ahead- despite shares already rallying 128% year-to-date.
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