Pluristem Reports Preliminary Data from its COVID-19 Compassionate Use Program, Treating Seven Patients with Acute Respiratory Failure

• All treated patients were in Intensive Care Units (ICU) on ventilators and suffered from Acute Respiratory Distress Syndrome (ARDS)
• 100% survival rate for all seven patients
• 6 patients completed 1 week follow up; the seventh patient was treated on April 5 2020
• 4 of the 6 (66%) patients that completed 1 week follow up demonstrated improvement in respiratory parameters
• 3 of the 6 (50%) patients that completed 1 week follow up are in advanced stages of weaning from ventilators  
• Pluristem plans to apply for initiation of multinational clinical trial for treatment of complications associated with COVID-19  

HAIFA, Israel, April 07, 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 preliminary data from its compassionate use program, treating seven patients suffering from acute respiratory failure and inflammatory complications associated with COVID-19 with Pluristem’s PLX cells, in three medical centers in Israel.  

Patients’ condition prior to the treatment with PLX cells
All seven patients approved for treatment under compassionate use program with PLX cells exhibited, prior to treatment, respiratory failure due to ARDS, which is a major cause of mortality and required mechanical ventilation in an ICU. Four of the patients also demonstrated failure of other organ systems, including cardiovascular and kidney failure, indicating critical disease and poor prognosis.   

Preliminary data following treatment with PLX cells
Six of the seven patients have completed the seven day follow up period (“Group A”). The seventh patient has not yet completed seven day follow up. 

• While the treated patients are considered high risk for mortality (Pavan K. Bhatraju et al. https://www.nejm.org/doi/full/10.1056/NEJMoa2004500), the preliminary data demonstrated 100% survival rate as of today.
• Four patients (66%) out of Group A demonstrated improvement in respiratory parameters.
• Three patients (50%) out of Group A are in advanced stages of weaning from ventilators.
• One patient has shown no change in respiratory parameters, is still breathing with the assistance of a ventilator and remains relatively stable.
• One patient has shown deterioration in respiratory parameters.
• Two patients (50%) out of four in Group A with multi-organ failure prior to treatment, showed clinical recovery in addition to the respiratory improvement.

Pluristem’s COVID-19 clinical development strategy