COVID-19 is caused by infection with the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that may cause clusters of severe respiratory illness associated with the need for intensive care unit (ICU) admission and high mortality. Studies have shown that Acute Respiratory Distress Syndrome (ARDS) following viral pneumonia is one of the most common causes of death from COVID-19,,,,.
A cytokine storm (CS) refers to excessive and uncontrolled release of pro-inflammatory cytokines that commonly present as systemic inflammation, multiple organ failure, and high inflammatory parameters. In coronavirus pneumonia, massive inflammatory cell infiltration and a CS lead to acute lung injury, ARDS and death,.
Clinical Development of PLX-PAD to Treat ARDS Associated with COVID-19
Pluristem conducted two phase II clinical studies to evaluate the efficacy and safety of intramuscular injections of PLX PAD for the treatment of severe COVID-19 complicated by ARDS in the U.S., Europe and Israel.
Topline Results from 89 Patients in the U.S., Europe & Israel
Efficacy trends from the Studies for patients treated with 300 million PLX-PAD cells:
- The U.S. study (N=14) showed an increased survival rate by 40% at day 60 compared to placebo group (N=14) (50% vs. 35%)
- The EU Study cells (N=11) showed an increased survival rate by 27% at day 60 compared to control group (N=12) (64% vs. 50%)
- The EU Study, showed increased ventilator free days at day 28 by 3.6 days, from 0.2 days in the control group (N=12) to 3.8 days in the treated group (N=11)
- The EU Study, showed increased ventilator free days at day 60 by 112% or 6.6 days, from 5.9 days in the control group (N=12) to 12.5 days in the treated group (N=11)
Compassionate Use Programs in Israel and the U.S. – Clinical Update for 8 Patients (May 14, 2020)
Pluristem reported a clinical update for 8 patients (1 in the U.S. and 7 in Israel) under compassionate use programs in Israel and the U.S., who had completed a 28-day follow-up period from a total of 18 patients at the time being treated:
- 87.5% survival rate
- 75% of patients were off any mechanical ventilation
- 62.5% of the patients were discharged alive from the hospital
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