Full Press Release Details
Enlivex: After Review of Phase II Data, Israeli Ministry of Health
Authorizes Initiation of a Multi-Center, Randomized Phase IIb Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients
Nes Ziona, Israel, August 15, 2021 (GLOBE NEWSWIRE) -- Enlivex
Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today reported
that after reviewing previously-reported Phase II trial data, the Israeli Ministry of Health has authorized the initiation of a proposed
Company-sponsored, multi-center, placebo-controlled, randomized, blinded, Phase IIb clinical trial evaluating AllocetraTM in
severe and critical COVID-19 patients with acute respiratory distressed syndrome (ARDS).
The Phase IIb trial is expected to recruit up to 152 severe or
critical COVID-19 patients in clinical centers in Israel and certain European countries, and is designed to assess the safety and efficacy
of AllocetraTM when administered in addition to standard of care treatment.
Enlivex previously reported positive
top-line results from Phase Ib and Phase II investigator-initiated clinical trials of AllocetraTM in COVID-19 patients
in severe and critical condition. Aggregate data from the two trials demonstrated that AllocetraTM
was safe and well tolerated. Moreover, at the end of the 28-day follow-up period, a 0% (0/21) mortality rate was observed and 90.5% (19/21)
of patients recovered from their respective severe/critical condition and were discharged from the hospital after an average of 5.6 days
following AllocetraTM administration.
The planned Phase IIb clinical trial will have two primary endpoints:
ventilation-free survival and recovery for each of the two sub-populations of patients in the study (severe and critical). In addition,
the trial will assess several secondary endpoints, including evaluation of long-COVID-19 symptoms.
Oren Hershkovitz, Ph.D., CEO of Enlivex, and Prof. Dror Mevorach,
Chief Scientific Officer of Enlivex, stated in a joint comment: "We would like to thank the Israeli Ministry of Health for the expedited
review and for authorizing a Phase IIb clinical trial of AllocetraTM in COVID-19 patients in severe and critical condition."
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 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, the expected timing of clinical trials' results for,
and market opportunities for, ALLOCETRATM programs, as well as potential changes in the severity level of the COVID-19
pandemic (including due to new variants of the virus) and the effect of such changes on pace of patient recruitment into clinical trials,
manufacturing delays, and changes in market opportunities. 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 be delayed and/or 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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