FDA clears Haifa-based Pluristem’s COVID-19 Expanded Access Program

More coronavirus patients who do not qualify for the company’s clinical trial will now be able to receive treatment

Biologists work in a laboratory at Pluristem Theraputics in Haifa (photo credit: BAZ RATNER/REUTERS)
Biologists work in a laboratory at Pluristem Theraputics in Haifa
(photo credit: BAZ RATNER/REUTERS)
The US Food and Drug Administration has approved the use of Pluristem’s PLX-PAD cells in patients who are suffering from acute respiratory distress syndrome brought on by COVID-19, but who do not qualify for the company’s clinical trial.
“The FDA clearance of our Expanded Access Program follows our recent experience treating COVID-19 patients under compassionate use programs in the US and Israel, and, we believe emphasizes the urgent medical need for new therapeutic options to treat COVID-19 patients who are critically ill,” said Pluristem president and CEO Yaky Yanay. “We believe that now is the time for governments and states to ensure medical centers throughout the United States can offer these crucial treatments on a large scale.”
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.”
Pluristem is based in Haifa. It is currently running a Phase II COVID-19 study in the US and Europe, which is testing the effectiveness of its PLX cells to induce the immune system’s natural regulatory T cells and M2 macrophages, and thus prevent or reverse the dangerous over activation of the immune system in COVID-19 patients – often the cause of their death.
Previous preclinical studies on animals showed therapeutic benefits against pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury – all potential complications of severe COVID-19.
In April, the company began testing its PLX cells on patients with COVID-19 under a compassionate use program in Israel and the FDA single patient EAP in the United States. All patients who received the treatment were in intensive care units, on invasive mechanical ventilation and suffered from acute respiratory syndrome at the time of treatment. One month later, Pluristem reported that 75% of those treated were off any mechanical ventilation within 28 days.
Pluristem’s updated EAP will include up to 100 patients. The resulting data will be collected and evaluated alongside the company’s clinical trial data.
“We are excited to offer expanded access to our PLX-PAD cell therapy for patients in need,” Yanay continued. “We, at Pluristem, are committed to harnessing our commercial-scale manufacturing capabilities to deliver on these requirements and make our novel PLX cells with favorable safety profiles available to all in need.”