Full Press Release Details
Enlivex Announces Dosing of First Two Patients
in its Randomized, Controlled Phase I/II Trial Evaluating
Allocetra in Patients with Knee Osteoarthritis
Nes-Ziona, Israel, April 22, 2024 (GLOBE NEWSWIRE)
-- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company,
today announced that the first two patients have been dosed in the Company's multi-country, randomized, controlled Phase I/II trial
evaluating AllocetraTM in up to 160 patients with moderate to severe knee osteoarthritis.
The Phase I/II multi-center trial is composed
of two stages. The first stage is a safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra
injections to the target knee in order to identify the dose and injection regimen for the second, randomized stage. The second stage is
a double-blind, randomized, placebo-controlled stage, which the Company expects to initiate following the completion of the safety run-in
stage and confirmation by the independent Data and Safety Monitoring Board. In addition to evaluating safety, the blinded randomized stage
is statistically-powered to assess the efficacy of Allocetra injections into the knee. The Company expects that the primary measurements
will evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months after treatment.
Einat Galamidi, MD., Vice President, Medical of
Enlivex, stated "We are pleased with the enrollment and dosing of the first two patients in the open-label stage of the trial. This
stage is designed to identify the dose and injection regimen for the randomized stage, and we look forward to the continued enrollment
of additional patients."
ABOUT KNEE OSTEOARTHRITIS1
Osteoarthritis is by far the most common form
of arthritis, affecting more than 32.5 million Americans and more than 300 million individuals worldwide. About half of knees with ACL
injuries develop osteoarthritis within 5 to 15 years. 78 million Americans are projected to have osteoarthritis by the year 2040. Symptomatic
knee osteoarthritis is particularly prevalent and disabling, with 40% of men and 47% of women developing knee osteoarthritis in their
lifetimes. Osteoarthritis accounts for over one million hospitalizations annually in the United States, primarily for total joint replacement.
The burden of osteoarthritis is enormous, and the need for treatments that reduce pain and attendant disability for persons with osteoarthritis
is critical. There are currently no medications approved by either the U.S. Food and Drug Administration or the European Medicines Agency
that have been demonstrated to arrest, slow or reverse progression of structural damage in the joint.
Allocetra 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, 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, Allocetra 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 Allocetra , 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 and life-debilitating 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.
INVESTOR RELATIONS CONTACT
RedChip Companies Inc.