- Enlivex Therapeutics ( NASDAQ: ENLV ) said that the Spanish Agency of Medicines and Medical Devices (AEMPS) authorized the expansion of its phase 1/2 trial of Allocetra in patients with advanced solid malignancies.
- The greenlight from the Spanish agency comes on the heels of similar clearances from regulators in the U.S. and Israel .
- The study will evaluate the off-the-shelf cell therapy Allocetra alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors.
- "We believe that AllocetraTM has the potential to provide a paradigm shift in treatment of advanced solid tumors, and we look forward to data readouts, including safety and potential indication of effect in patients, currently expected during 2023 and 2024," said Einat Galamidi, vice president, Medical of Enlivex.
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Enlivex's trial of cell therapy Allocetra for tumors gets clearance in Spain