Full Press Release Details
Enlivex Announces Dosing
of First Patient Under The Amended Protocol Of Its Phase II trial Evaluating Allocetra In Patients With Sepsis
Nes-Ziona, Israel, Jul 31, 2023 (GLOBE NEWSWIRE)
- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy
company, today announced that the first patient has been dosed under the amended protocol for the Company's Phase II trial evaluating
Allocetra in patients with sepsis. As previously announced, the amended protocol allows a higher SOFA score inclusion range, which
allows the recruitment of patients with higher levels of sepsis severity. Additionally, the amended protocol provides for two cohorts
(treatment and placebo) rather than the prior protocol's four-cohort structure.
"We are pleased that the approval
of the amended protocol in France, Belgium and Netherlands aligns with the Company's planned timeline for the initiation of recruitment
as per the amended protocol," stated Oren Hershkovitz, CEO of Enlivex. "Therefore, we believe that the top-line data readout
from the Phase II trial will be in Q1 2024, which is consistent with our previously announced timeline."
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.
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.
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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