Business
Enlivex Announces Third Quarter 2021 Financial Results and Provides a Business Update
Initiated dosing in placebo-controlled Phase IIb clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients with ARDS Received
About this update from Enlivex Ltd.
[{"type":"text","content":"Initiated dosing in placebo-controlled Phase IIb clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients with ARDS Received authorization to expand ongoing sepsis and COVID-19 trials into Spain Initiated design and construction process for a new cGMP AllocetraTM manufacturing plant Nes Ziona, Israel, Nov. 22, 2021 (GLOBE NEWSWIRE) -- -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it filed its financial results and related discussion for the third quarter ended September 30, 2021 with the SEC on November 19, 2021. “We are advancing towards 2022 with a strong balance sheet, expanded leadership team, and compelling clinical and preclinical data that we believe demonstrate Allocetra’s potential as a next generation cell therapy for infectious, inflammatory and oncologic diseases,” said Oren Hershkovitz, Ph.D., CEO of Enlivex. “Our ongoing sepsis and COVID-19 trials were recently granted authorization for expansion into sites in Spain, which positions us to broaden our therapeutic impact while also providing important regulatory validation for our study designs and manufacturing process. To support these and our other programs, we also initiated the design and construction process for a new cGMP manufacturing plant. This plant will importantly allow us to be prepared for larger clinical trials and the potential commencement of commercial activities.” Dr. Hershkovitz continued, “Alongside this recent regulatory and corporate progress, we have continued to advance our solid tumor program towards the initiation of two planned clinical trials. Through the advancement of these trials, we aim to clinically demonstrate Allocetra’s potential to combine synergistically with currently available cancer therapies and improve response rates for difficult-to-treat cancer patients. Looking ahead, we expect our solid tumor, sepsis, and COVID-19 programs to gain momentum as we work to address life-threatening conditions through Allocetra’s clinical development.” Business Highlights and Upcoming Milestones Sepsis: Enlivex's immunotherapy product candidate AllocetraTM is being evaluated in a placebo-controlled, randomized, dose-finding, multi-center, Phase II trial in patients with pneumonia-associated sepsis. The trial, which has m...