Clinical outlook for prevention of complications post-bone marrow transplant
Enlivex has conducted a Phase IIa clinical study to evaluate the safety, tolerability, and preliminary efficacy profile of Allocetra for preventing post-BMT complications. The study showed that Allocetra has the potential to induce immunotolerance and rebalance the immune system to normal activity levels post-BMT – preventing Cytokine Release Syndrome and BMT-associated complications. Patients who received effective doses of Allocetra experienced no GvHD grade II-IV and were discharged from hospital after an average of 21 days compared to the expected 41-45 days. Allocetra has been well-tolerated, showing no observable, significant adverse side effects.
The Company’s timeline for the continued development of Allocetra™ from either matched-donor cells or off-the-shelf source for the prevention of GvHD in allogeneic HSCT patients has been modified to reflect the Company’s re-prioritization of product development in light of the encouraging results of the Phase Ib of Allocetra™ in patients with severe sepsis. As a result, the planned continuation of additional clinical trials of Allocetra™ from either matched-donor cells or off-the-shelf source for the prevention of GvHD in allogeneic HSCT patients have been rescheduled to 2022, pending the expected results of clinical trials in sepsis and potentially other related indications during 2020-2022.