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Enlivex Announces Positive DSMB Recommendation to Initiate the Phase II Stage of its Phase I/II Trial of Allocetra in Patients with Moderate to Severe Knee Osteoarthritis
Nes-Ziona, Israel, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company"))), a clinical-stage macrophage reprogramming immunotherapy company, today 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.
The Phase I/II multi-center trial is composed of two stages. The first stage is a Phase I safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra™ injections to the target knee in order to identify the dose and injection regimen for the subsequent Phase II stage. The Phase II stage is double-blind, randomized, placebo-controlled stage, which the Company is now initiating following the completion of the safety run-in Phase I stage and the safety confirmation by the DSMB. In addition to evaluating safety, the blinded randomized stage is statistically-powered to assess the efficacy of Allocetra™ injections into the knee. The Company expects that the primary measurements will evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months after treatment.
The Phase I/II multi-center trial is composed of two stages. The first stage is a Phase I safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra™ injections to the target knee in order to identify the dose and injection regimen for the subsequent Phase II stage. The Phase II stage is double-blind, randomized, placebo-controlled stage, which the Company is now initiating following the completion of the safety run-in Phase I stage and the safety confirmation by the DSMB. In addition to evaluating safety, the blinded randomized stage is statistically-powered to assess the efficacy of Allocetra™ injections into the knee. The Company expects that the primary measurements will evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months after treatment.
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