Enlivex Therapeutics Ltd. ENLV announced that the U.S. Food & Drug Administration (FDA) had cleared an Investigational New Drug (IND) application to study Allocetra™ in patients with advanced solid malignancies.
The FDA’s Phase I/II clearance follows a recent announcement by the Company that the first patient has been dosed in Phase I/II multi-center clinical trial in Israel designed to evaluate the safety, tolerability, and preliminary efficacy of Allocetra™ stand-alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors.
Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex, stated, "We are pleased with the FDA’s regulatory clearance for our IND. The formal initiation of clinical development of AllocetraTM for oncology indications in the United States represents a significant milestone for Enlivex. We believe that AllocetraTM has the potential to provide a paradigm shift in the treatment of advanced solid tumors, and we look forward to observing safety and a potential indication of effect in patients, who we expect to enroll in several open-label Company-sponsored and investigator-initiated oncology trials during 2023.”
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