Full Press Release Details
Enlivex Therapeutics Announces
Plan for Increased Production Capacity of AllocetraTM in
Preparation for Potential Treatment of Coronavirus (COVID-19)
Patients with Organ Failure
Nes-Ziona, Israel, February 24, 2020
- 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.
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.
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.