Enlivex Therapeutics ( NASDAQ: ENLV ) announced Wednesday that the Israeli Ministry of Health (IMOH) greenlighted further patient enrollment to the company’s Phase I/II trial for cell therapy candidate Allocetra in solid tumors following a review by the trial’s safety panel.
Enlivex ( ENLV ) is advancing the multicenter, open-label to test Allocetra, off-the-shelf cell therapy in up to 48 patients with advanced solid tumors.
The independent Data and Safety Monitoring Board (DSMB) has based its analysis on safety data for the three patients in the first cohort who received Allocetra as monotherapy in three once-weekly, low-starting doses.
“There were no mortalities nor DSMB-identified safety signals in the first cohort, and the DSMB recommended that the study continue as designed,” the company stated, adding that following the DSMB nod, IMOH has reviewed the data to clear the addition of two more cohorts.
Those patients are set to receive Allocetra either as monotherapy or in combination with anti-PD1 therapy.
Read: Seeking Alpha contributor, Eric Egana argues that early data for Allocetra in sepsis and solid tumors “look incredible.”
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Enlivex cleared to expand clinical trial for cell therapy candidate