Enlivex Therapeutics Announces Plan for Increased Production Capacity of AllocetraTM in Preparation for Potential Treatment o...
February 24 2020 - 6:30AM
Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage
immunotherapy company, today announced that it is initiating a plan
to increase its manufacturing capacity of AllocetraTM, following
the first confirmed coronavirus (COVID-19) case in Israel, in
preparation for potential requests for treatment of coronavirus
(COVID-19) patients who are hospitalized with diagnosed organ
dysfunctions or failures related to coronavirus.
AllocetraTM is an experimental therapy being
investigated for treatment of patients with organ failure
associated with sepsis, a syndrome whose lethal pathophysiology –
cytokine storm followed by organ failure – is similar to that of
the coronavirus (COVID-19).
Sepsis is the 3rd leading cause of
mortality in the United States. One of every three patients who die
in U.S. hospitals dies from sepsis. Organ failure resulting from
sepsis, as well as in coronavirus (COVID-19), is considered the
result of an exaggerated response of the immune system (”cytokine
storm”) in the human body to an infection by a virus or a
bacteria.
This exaggerated immune response results in
organ damage. The immune attacks typically occur in vital organs
such as lungs, heart, kidney and liver. When the organs become
distressed, they begin to slowly dysfunction, which can result in
organ failure, multiple organ failure, and mortality. Mortality
rates from sepsis vary upon the degree of organ failure with which
the patient arrived at the hospital. The literature describes an
average of 20-40% mortality within 28-90 days for sepsis patients
admitted to the ICU in a state of organ failure. Similarly, a
cytokine storm was recently reported in patients with COVID-19 that
were hospitalized in the ICU, (Huang et al. www.thelancet.com
Published online January 24, 2020
https://doi.org/10.1016/S0140-6736(20)30183-5) and patients
admitted to ICU had higher plasma levels of cytokines and
chemokines.
There is no currently approved treatment for
sepsis or for complicated corona virus infections. Enlivex recently
announced the interim results from its first clinical trial in
patients with sepsis. When compared with matched historical
controls with sepsis from the same hospital, there were clear
differences in (i) mortality -- none of the six Allocetra-treated
patients died, vs 29% mortality in 28 days for the matched controls
group; (ii) organ failure measures – 78% of the matched controls
had an increase of organ failure markers post admission to the
hospital, while none (0%) of the six treated patients had any
increase in organ failure score, despite similar presentation, and
the average organ failure state of the matched controls worsened by
a factor of two, while the treated group had not a single case of
any organ failure increase; (iii) all the treated patients had
their organ failures eliminated and they were subsequently released
from the hospital. Each of the patients had organ dysfunction in
two to five systems prior to administration of Allocetra. A Full
summary of this trial is expected to be published in March
2020.
Enlivex has publicly announced its plan to
initiate in 2020 two clinical studies: (i) a Phase II/III clinical
trial for sepsis later in the year, and (ii) a Phase II/III for the
prevention of GvHD in patients who undergo bone-marrow
transplantations. The manufacturing capacity of Allocetra was
planned to match the expected recruitment rate of patients in those
two clinical trials.
To accommodate potential requests for treatment
of COVID-19 patients who are hospitalized with diagnosed organ
dysfunctions and/or failures, Enlivex has initiated a plan to
increase the production capacity of Allocetra.
ALLOCETRATM by Enlivex was designed
to provide a novel immunotherapy mechanism of action that
targets life-threatening clinical indications that are defined as
“unmet medical needs”, including prevention or treatment of
complications associated with bone marrow transplantations (BMT)
and/or hematopoietic stem cell transplantations (HSCT); organ
dysfunction and acute multiple organ failure associated with
sepsis; and enablement of an effective treatment of solid tumors
via immune checkpoint rebalancing.
ABOUT ENLIVEX
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 an out of control immune system (e.g. 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”, “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, which 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 under the heading “Risk Factors” contained in
Enlivex’s most recently filed Annual Report on Form 20-F. 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.
ENLIVEX CONTACT:Shachar Shlosberger, CFOEnlivex Therapeutics,
Ltd.shachar@enlivex-pharm.com
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