The Haifa-based company Pluristem announced announced Wednesday that it has received approval from the Health Ministry to expand an existing Phase II clinical trial of its treatment for COVID-19 to Israel.
A total of 40 patients hospitalized with severe COVID-19 complicated by acute respiratory distress syndrome (ARDS) will now be enrolled at clinical sites in Israel and Germany, following a protocol that was approved by Germany’s regulatory agency.
“We believe that the approval from the Israeli Ministry of Health will enable us to advance the treatment of severe COVID-19 patients,” Pluristem CEO Yaky Yanay said. “As the pandemic continues in Israel, we see it as our mission to treat those severe patients in need.”
Pluristem is treating COVID-19 patients with its PLX-PAD novel, placenta-derived cellular therapy.
Yanay explained to The Jerusalem Post that accumulated evidence shows that many of the patients who fall victim to coronavirus die because of an increase in the production of inflammatory molecules called cytokine, rather than the virus itself.
When the immune system secretes too many cytokines, a so-called cytokine storm can erupt and damage the body’s lungs and other organs. Such an excessive immune response ravages healthy lung tissue, leading to ARDS and multi-organ failure, the most common causes of death in COVID-19 patients.
PLX-PAD has immunomodulatory and cytoprotective properties that could play a meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs.
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The therapy, which has been administered through compassionate use programs in Israel and the US, has been found to protect patients from deteriorating and speed their recovery.
Yanay said that the primary efficacy endpoint of the trial is the number of ventilator-free days during the 28 days following treatment. Safety and survival follow-up will be conducted up to week 52.
Twenty patients who receive PLX-PAD will be compared to a control group that will receive standard of care treatment.
In April, Pluristem published preliminary data on six critically ill coronavirus patients in Israel, who were considered high-risk for mortality, were treated with Pluristem’s placenta-based cell-therapy product and survived.
In May, the cell therapy was cleared by the US Food and Drug Administration for a Phase II study in the treatment of severe COVID-19 cases complicated by ARDS. Then, in August, the FDA gave the company clearance to treat additional patients through its Expanded Access Program.
The FDA website explains that expanded access is “a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials.”
Yanay said that, with the expanded trial, he hopes that there will be more data faster and the company will be able to apply for FDA conditional approval, which allows drug companies to legally sell their drugs before receiving full FDA approval.
“With our broad COVID-19 clinical programs in Europe and the US, we are committed to advancing our research and developing a treatment that may help save lives,” Yanay added.
He said that, “We are excited about how this is going and we hope to be part of the solution to regaining control of this virus.”
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