Full Press Release Details
Enlivex Announces Initiation of Multi-Center Phase II Investigator-Initiated
Clinical Trial of Allocetra in COVID-19 Patients
May 06, 2020 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage immunotherapy company, today
announced that an investigator-initiated multi-center Phase II clinical trial of AllocetraTM (formerly referred
to as off-the-shelf AllocetraTM) in COVID-19 patients has commenced.
investigating the exact pathophysiology of COVID-19 is ongoing, recent publications have described the complications related to
the virally induced COVID-19 disease as associated with organ dysfunction and cytokine storms, which are markedly similar to those
observed in septic patients in the ICU," said Prof. Vernon van Heerden, Head of the Critical Care Medicine Unit at Hadassah
Hospital in Israel, and the lead investigator of both the COVID-19 trial and a recently-completed Phase Ib clinical trial of AllocetraTM in
sepsis patients. "Therefore, based on compelling preliminary results from the Phase Ib trial that demonstrated safety and
an indication of efficacy of AllocetraTM in patients with severe sepsis admitted to the ICU, Enlivex's product
candidate may potentially be beneficial for COVID-19 patients with moderate to severe symptoms. We expect that the current study
will build on these recent findings by evaluating the potential relationship between cytokine storms and COVID-19-induced organ
Prof. Dror Mevorach,
M.D., Chief Scientific and Medical Officer of Enlivex, added "This newly initiated study represents a unique opportunity
for Enlivex to contribute towards efforts aimed at combating the ongoing global COVID-19 pandemic. We are eager to learn if the
initial positive results seen in sepsis patients treated with AllocetraTM translate to COVID-19 patients with similar
underlying pathologies. Further, the scientific insights that could be gained from this study may facilitate the development of
other COVID-19 therapies, as well as AllocetraTM-based treatment plans for diseases in addition to sepsis."
is a multi-center investigator-initiated, Phase II clinical trial. The trial is expected to recruit up to five patients in each
participating center and is designed to assess AllocetraTM in combination with standard of care therapy in patients
with COVID-19 associated lung dysfunction. Safety, tolerability, cytokine profile and efficacy parameters will be evaluated, with
change in PaO2/FiO2 ratio number and severity of adverse events and serious adverse events serving as the co-primary study endpoints.
study is expected to run independently of Enlivex's currently planned Phase IIb clinical trial of
AllocetraTM for the treatment of sepsis. The planned Phase IIb trial will be a controlled, randomized study
that is expected to commence in the fourth quarter of 2020.
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), as well as solid
tumors immune-checkpoint rebalancing. 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.