On December 3, 2020, the Company reported positive interim results of a Phase II investigator-initiated clinical trial of Allocetra in COVID-19 patients in severe/critical condition.
The interim clinical results relate to eight COVID-19 patients who were treated with AllocetraTM in the Phase II clinical trial, six of whom were in severe condition and two of whom were in critical condition. Key results and conclusions from both the ongoing Phase II clinical trial, as well as a previously-reported investigator-initiated Phase Ib study include:
- Seven out of seven (100%) patients treated through November 26, 2020 had complete recovery from their respective severe/critical condition and were discharged from the hospital, after an average of 4.7 days following AllocetraTM administration.
- Taken together with previously-treated patients in the concluded Phase Ib study, twelve out of twelve patients (100%) through November 26, 2020 had complete recovery from their respective severe/critical condition and were discharged from the hospital, after an average of 5.5 days following AllocetraTM administration.
- The eighth treated patient in the Phase II study (and 13th treated patient overall), who enrolled in the Phase II study in critical condition on November 27, 2020, has experienced a clinical improvement following treatment with AllocetraTM and was classified as moderate/severe condition on December 3, 2020. Clinical outcome will be included in the next interim results update.
- AllocetraTM treatment has been well tolerated with no treatment-related serious adverse events.