HAIFA, Israel, Aug. 27, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Expanded Access Program (EAP) for the use of its PLX-PAD cells to treat Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19 outside of the Company’s ongoing Phase II COVID-19 study in the U.S. The program provides a pathway for patients that are not eligible for inclusion in the Phase II clinical trial to be treated with PLX-PAD cells. The EAP will include up to 100 patients, with the resulting data collected and evaluated alongside Pluristem’s clinical trial.
“We are excited to offer expanded access to our PLX-PAD cell therapy for patients in need who are suffering from severe complications of COVID-19,” stated Pluristem CEO and President, Yaky Yanay. “The FDA clearance of our EAP follows our recent experience treating COVID-19 patients under compassionate use programs in the U.S. and Israel, and, we believe emphasizes the urgent medical need for new therapeutic options to treat COVID-19 patients who are critically ill. 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. 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.”
Alongside the EAP in the U.S., Pluristem will continue to advance its two ongoing COVID-19 Phase II clinical trials of its PLX-PAD product candidate for the treatment of severe ARDS in the U.S. and Europe, and treat patients under the compassionate use program in Israel.