Enlivex announces DSMB recommendation to initiate Phase II stage of Allocetra

Enlivex Therapeutics announced that the independent Data and Safety Monitoring Board, DSMB, has completed an interim data review at the conclusion of the Phase I safety run-in stage of the Company’s ongoing Phase I/II clinical trial of Allocetra in up to 160 patients with moderate to severe knee osteoarthritis. Patients in the Phase I safety run-in were treated with three sequential injections of Allocetra at escalating doses, and no serious adverse reactions were reported during or following the treatment. Following review of the data, the DSMB confirmed that the safety profile of Allocetra allows the Company to move forward to the Phase II stage of the Phase I/II trial, which is a double-blind, randomized evaluation of the safety and efficacy of intra-articular knee injections of Allocetra compared to placebo. The DSMB has also indicated that in light of the observed safety profile, the Phase II stage may proceed with the highest dose of Allocetra injections tested in the Phase I safety run-in.