Full Press Release Details
Spanish Regulator Grants Enlivex Authorization To Expand Its Sepsis
Nes Ziona, Israel, November 4, 2021 (GLOBE NEWSWIRE) -- Enlivex
Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today announced
that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the expansion to clinical sites in Spain of the Company's
multi-center, placebo-controlled, randomized, dose-finding, Phase II trial of AllocetraTM in patients with pneumonia-associated
The Phase II trial, which has multiple sites open for enrollment
in Israel, is expected to include 120 to 160 patients across four cohorts receiving varying doses of AllocetraTM or placebo,
all in addition to standard-of-care therapy. The trial's two primary endpoints are safety (number and severity of adverse events and severe
adverse events) and efficacy (change from baseline in sequential organ failure (SOFA) score) assessments throughout a 28-day follow-up
period. The trial is supported by previously reported positive results from a Phase Ib investigator-initiated trial, showing vastly improved
clinical outcomes, including SOFA scores, duration of hospitalization, and mortality, in AllocetraTM-treated sepsis patients,
as compared to a group of matched historical controls who received standard-of-care therapy.
Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, "Receiving
authorization to expand our sepsis trial to Spain is an important first step in our broader plan to include several European countries
as part of our ongoing clinical trials. We believe this also represents a notable regulatory achievement that provides additional validation
for our study design and Allocetra's manufacturing process, which was reviewed by the Spanish regulator as part of its review process.
We would like to thank AEMPS for their review and look forward to the continued advancement of our sepsis program across both Europe
AllocetraTM is being developed as a universal, off-the-shelf
cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many
others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity
of the respective diseases. By restoring macrophage homeostasis, AllocetraTM has the potential to provide a novel immunotherapeutic
mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy
or in combination with leading therapeutic agents.
Enlivex is a clinical stage macrophage
reprogramming immunotherapy company developing AllocetraTM, a universal, off-the-shelf cell therapy designed to reprogram macrophages
into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing
and resolution of life-threatening conditions. For more information, visit http://www.enlivex.com.
Safe Harbor Statement: This press
release contains forward-looking statements, which may be identified by words such as "expects," "plans," "projects,"
"will," "may," "anticipates," "believes," "should," "would", "could,"
"intends," "estimates," "suggests," "has the potential to" and other words of similar meaning,
including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical
experiments, the effectiveness of, and market opportunities for, ALLOCETRATM programs. All such forward-looking statements
are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that
forward-looking statements involve risks and uncertainties that may affect Enlivex's business and prospects, including the risks that
Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may
not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products
for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity;
and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements.
The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in
animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development
of any products using the ALLOCETRATM product line could also be affected by a number of other factors, including unexpected
safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical
industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors
and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental,
technological and other factors discussed in Enlivex's filings with the Securities and Exchange Commission, including in the Company's
most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in
this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking
statements, except as required under applicable law.
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
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