Full Press Release Details
Enlivex Announces the Dosing of the First Patient
in a Phase I Trial Evaluating Allocetra in Patients with TMJ Osteoarthritis
Ness-Ziona, Israel, April 03, 2025 (GLOBE
NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company" or "Enlivex"), a clinical-stage
macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed in an investigator-initiated
Phase I trial to evaluate the safety, tolerability and initial efficacy of Allocetra for injection into the temporomandibular
joint (TMJ) in patients suffering from TMJ osteoarthritis.
The study will be conducted by the Rheumatology Unit at Sheba Medical
Center in collaboration with the Department of Oral and Maxillofacial Surgery at Sheba Medical Center. Notably, Sheba Medical Center was
recently ranked among the top 10 hospitals in the world by Newsweek.
Dr. Einat Galamidi, CMO of Enlivex, commented, "This study will
provide a preliminary evaluation of the safety and potential effect of AllocetraTM for the treatment of TMJ osteoarthritis,
which affects a joint that is critical for daily function. We are pleased to report that the injection of AllocteraTM into
the first patient's TMJ was successfully completed with no complications."
The trial currently plans to recruit six patients who have insufficiently
responded to conventional therapies for TMJ osteoarthritis. The trial's primary safety endpoint will measure the frequency and severity
of adverse events and serious adverse events, and efficacy endpoints will assess changes from baseline in TMJ pain, joint functionality,
and other disease parameters for up to 12 months following administration of Allocetra .
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.
ABOUT Temporomandibular
Joint (TMJ) OSTEOARTHRITIS
TMJ disorders are the second most common musculoskeletal
condition affecting five to 12% of the population globally, with an annual health cost estimated at $4 billion1. Osteoarthritis
of the TMJ is the most common form of arthritis in the TMJ, causing pain and stiffness in the jaw. It may become difficult to chew. TMJ
osteoarthritis is a degenerative disease of the joint, which culminates in the progressive destruction of all soft and hard tissue components
of the TMJ. For patients who present in early adulthood with severe clinical symptoms and catastrophic radiographic changes, there are
significant implications for management, including the potential need for early total joint replacement. There are currently no effective
long-term treatments for this disease2.
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 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, expected clinical trial results, 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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