Full Press Release Details
Enlivex Announces Positive DSMB Recommendation to Initiate the
Phase II Stage of its Phase I/II Trial of Allocetra in Patients with Moderate to Severe Knee Osteoarthritis
Nes-Ziona, Israel, Sept. 24,
2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming
immunotherapy company, today announced that the independent Data and Safety Monitoring Board (DSMB) has completed an interim data review
at the conclusion of the Phase I safety run-in stage of the Company's ongoing Phase I/II clinical trial of Allocetra in up
to 160 patients with moderate to severe knee osteoarthritis. Patients in the Phase I safety run-in were treated with three sequential
injections of Allocetra at escalating doses, and no serious adverse reactions were reported during or following the treatment.
Following review of the data, the DSMB confirmed that the safety profile of Allocetra allows the Company to move forward to the
Phase II stage of the Phase I/II trial, which is a double-blind, randomized evaluation of the safety and efficacy of intra-articular knee
injections of Allocetra compared to placebo. The DSMB has also indicated that in light of the observed safety profile, the Phase
II stage may proceed with the highest dose of Allocetra injections tested in the Phase I safety run-in.
The Phase I/II multi-center trial is composed of two stages. The
first stage is a Phase I 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 subsequent Phase II stage. The Phase II stage
is double-blind, randomized, placebo-controlled stage, which the Company is now initiating following the completion of the safety run-in
Phase I stage and the safety confirmation by the DSMB. 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.
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 (FDA) or the European Medicines Agency (EMA) that have
been demonstrated to arrest, slow or reverse progression of structural damage in the joint.
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 https://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.
1 Source: The Arthritis Foundation; Disease modification in osteoarthritis; pathways to drug approval, Katz et. Al., Osteoarthritis and Cartilage Open (2) (2020)