The 28-day study period is also the primary endpoint timeline for Pluristem’s recently announced FDA Phase II study.
28-day follow up highlights for 8 patients treated with PLX cells:
- The survival rate of the 8 patients treated with PLX cells was 87.5%
- 75% were off any mechanical ventilation
- 62.5% were discharged alive from the hospital compared to 3.3% (38 out of 1151 patients) in data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive.
The Company intends to provide a final update regarding the compassionate use program in Israel and the FDA Single Patient Expanded Access Program in the U.S. once it has completed such programs and after it has completed its previously announced Phase II study with respect to the use of its PLX cells for the treatment of severe redacted cases complicated by ARDS.
“We are highly encouraged by this data. The 28-day follow up time marker is important, as our Phase II study’s primary efficacy endpoint is the number of ventilator free days during the 28-day study period from day 1 though day 28,” stated Pluristem CEO and President, Yaky Yanay. “We are currently focused on initiating the Phase II clinical study in the U.S., where we expect to treat the first patient in the coming days. Simultaneously, we continue to help treat patients through our compassionate use and FDA Single Patient Expanded Access Programs in Israel and the U.S.”
PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities. Pluristem believes its PLX cells will offer a key advantage in addressing the redacted global redacted. PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may prevent or reverse the dangerous overactivation of the immune system. Accordingly, PLX cells may potentially reduce the incidence and/or severity of redacted pneumonia and pneumonitis leading hopefully to a better prognosis for the patients. 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 redacted infection. Clinical data using PLX cells demonstrated the strong immunomodulatory potency of PLX cells in patients post major surgery. Taken together, PLX cells’ potential capabilities with the safety profile observed from clinical trials involving hundreds of patients worldwide potentially position them as a therapy for mitigating the tissue-damaging effects of redacted.