Full Press Release Details
Enlivex Announces Peer-Reviewed
Publication in Frontiers in Immunology of Clinical Data Details Resolution of Acute Respiratory Distress Syndrome (ARDS) from two Phase
I/II Trials Evaluating Allocetra in Patients with COVID-19
Data published in Frontiers
in Immunology show a robust safety profile and rapid resolution from ARDS and parallel resolution of inflammation markers and elevated
cytokines/chemokines, as well as substantial improvements in mortality in 21 Allocetra-treated patients with COVID-19 vs. matched historical
Nes-Ziona, Israel, Aug 2, 2023 (GLOBE NEWSWIRE) - Enlivex
Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today announced
the peer-reviewed publication of clinical and exploratory data from a Phase Ib and a Phase IIa clinical trial in Frontiers in Immunology.
The paper, entitled "Apoptotic cells for treatment of acute respiratory distress syndrome (ARDS) associated with COVID-19"
describes a multicenter study that was published in collaboration with researchers at Hadassah-Hebrew University Medical Center, Barzilai
Medical Center and Ziv Medical Center Israel.
Data presented in the paper was derived from
21 severe and critical COVID-19 patients treated with a single dose of AllocetraTM in addition to standard of care during
the peak of the COVID-19 pandemic. 19 out of the 21 treated patients had mild-to-severe ARDS with their COVID-19. The Phase I/II clinical
trials evaluated the safety profile of Allocetra treatment as well as recovery from ARDS, intensive care unit (ICU) and hospital length-of-stay
inflammatory parameters and cytokine/chemokine profile. The mortality rate was compared to a matched control group hospitalized during
the same period at Hadassah Medical Center.
"This study had excellent results, leading
to early discharge from a hospital of 17 out of 19 patients with ARDS along with resolution of the cytokine storms observed in these
patients. We believe that the current peer-reviewed publication provides an additional important external validation for AllocetraTM
and its broadly applicable mechanism of action in treating ARDS that manifested due to viral infection complications such as severe
and critical COVID-19," said Prof. Dror Mevorach, M.D., Chief Scientific Officer of Enlivex and lead author of the publication.
"ARDS is a difficult disease indication with poor treatment options
for patients. The global ARDS market size is estimated at approximately $1 billion, and is expected to reach more than $2 billion by 2030,"
stated Oren Hershkovitz, CEO of Enlivex. "We believe AllocetraTM could potentially become a leading therapy for ARDS
patients, and while Enlivex's clinical development slate is currently full with multiple clinical trials ongoing and planned for
2024, we will be seeking out-licensing or partnering opportunities to potentially continue via a third party the clinical development
of AllocetraTM for ARDS."
Key data and conclusions from the paper include:
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.
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.
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