Full Press Release Details
Enlivex Reports Positive Two-Year
Clinical Outcome For A Hospitalized Patient with Erosive Osteoarthritis Treated with Allocetra
short and long-term clinical improvement for a hospitalized patient with a rare disease that currently
has no effective treatment
Nes Ziona, Israel, November
18, 2020 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage immunotherapy
company, today reported a positive two-year clinical outcome following the first Allocetra treatment of a hospitalized
patient with erosive osteoarthritis, a rare bone disease, which has no approved nor effective treatment options and typically
involves rapid destruction of hip and shoulder bones. This was the sole erosive osteoarthritis patient who has been treated with
A 70-year-old patient experienced
a four-year inflammatory and erosive process of the right shoulder, resulting in complete destruction of the humeral head on X-ray,
significant inflammatory reaction on MRI, and significantly elevated inflammatory biomarkers in the shoulder, including erythrocyte
sedimentation rate (ESR) and C-reactive protein (CRP). Following regulatory approvals for compassionate use, the patient was treated
with five consecutive weekly intra-shoulder joint infusions of autologous Allocetra (100 x 106 cells). Prior
to receiving AllocetraTM, the patient had been hospitalized for more than nine months, and treatments with steroids,
antibiotics and other procedures had been ineffective.
Following AllocetraTM treatment,
the patient improved considerably and was released from the hospital following the initial administration of
AllocetraTM. A significant reduction in shoulder swelling was observed, with fluid drainage from the shoulder
declining from 150-250 ml/day to <60 ml/day. CRP declined by 93%, from 7.34 pre-treatment, to 0.49 after treatment,
which is within the normal range. Pro-inflammatory cytokines and chemokines within the treated shoulder joint that are
related to monocyte, macrophage, dendritic cell, osteoclast, neutrophil, and T cell activation were downregulated, most
notably IL-22 (a marker of dysregulation of wound healing of synovial tissue), IL-8 (a neutrophilic chemotactic factor), IL-6
(a marker of innate immunity), IL-9 (a marker of apoptosis prevention) and MIP-1-beta (a marker of chronic
At a 24-month follow-up, the
patient's CRP level in the diseased shoulder remained within normal range. The shoulder remained without swelling, and the
clinical improvement was maintained without any need for drainage or re-hospitalization during the 24-month period following the
Allocetra treatment.
Dror Mevorach, Chief
Medical Officer of Enlivex, stated, "These results are encouraging, demonstrating the potential of Allocetra as
a solution for a variety of clinical indications that may be characterized by local intra-joint cytokine storms or
dysregulations that still remain without any effective treatment. Joint-related diseases that are considered unmet medical
need range from rare diseases, such as erosive osteoarthritis, to osteoarthritis, which affects more than 30 million people
in the U.S. alone. We believe that the long-term effect of a single five-week course of Allocetra treatment on this
erosive osteoarthritis patient was remarkable."
AllocetraTM is currently
being evaluated in clinical studies in other diseases related to hyper-expression of cytokines such as sepsis and COVID-19. Enlivex
recently reported positive top-line results from a Phase Ib investigator-initiated clinical trial of AllocetraTM in
COVID-19 patients in severe and critical condition in Hadassah Hospital, one of the largest hospitals in Israel. The Phase Ib
clinical trial included five COVID-19 patients, three in severe condition and two in critical condition. All five patients completely
recovered from their respective severe/critical condition and were released from the hospital after an average of 5 days (severe)
and 9 days (critical), following administration of AllocetraTM, at which time they were all COVID-19 PCR negative.
There were no reported severe adverse events relating to the administration of AllocetraTM in the patients, and the
therapy was well-tolerated.
Enlivex is a clinical stage immunotherapy company, developing an allogeneic drug pipeline for immune system rebalancing. Immune
system rebalancing is critical for the treatment of life-threatening immune and inflammatory conditions which involve hyper-expression
of cytokines (Cytokine Release Syndrome) and for which there are no approved treatments (unmet medical needs) such as sepsis and
COVID-19, as well as enhancement of immune activity against solid tumors in combination with CAR-T or immune checkpoint therapies.
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.
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