Full Press Release Details
Announces Authorization from the Danish Regulatory Agency for the Company's Randomized, Controlled Phase I/II Trial Evaluating
Allocetra in Patients with Knee Osteoarthritis
Nes-Ziona, Israel, April 16, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage
macrophage reprogramming immunotherapy company, today announced that the Danish Medicines Agency (DKMA) authorized the expansion into
Denmark of the Company's multi-country, randomized, controlled Phase I/II trial evaluating AllocetraTM in up to 160
patients with moderate to severe knee osteoarthritis. As previously announced, the Company received its first regulatory approval for
this trial from the Israeli Ministry of Health (IMOH) in January.
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.
Hershkovitz, Ph.D., CEO of Enlivex, commented "We are excited to push ahead with the clinical development of AllocetraTM
in osteoarthritis. The approval of the study in Denmark, which is expected to be the leading recruiting country in the trial, marks an
important step, as this is the first approval for this trial by a European agency. The Danish sites are experienced in conducting osteoarthritis
studies with high recruitment rates and high quality."
KNEE OSTEOARTHRITIS1
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.
Source: The Arthritis Foundation; Disease modification in osteoarthritis; pathways to drug approval, Katz et. Al., Osteoarthritis
and Cartilage Open (2) (2020)
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.
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
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.