Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage
immunotherapy company, today announced positive final safety and
efficacy data from the Company’s completed Phase Ib clinical trial
in patients with severe sepsis. The final analysis compared the
clinical data of 10 patients admitted to the intensive care unit
with sepsis who were administered off-the-shelf AllocetraTM
(“Allocetra-OTS”) upon their admission, with 37 patients who were
matched controls (matched by age, gender, Sequential Organ Failure
Assessment (SOFA) score, and infection source) who received only
the standard of care treatment at the same hospital during
2014-2019 but did not receive Allocetra-OTS. The clinical trial was
conducted at Hadassah Medical Center, which is one of the largest
and most prestigious hospitals in Israel (“Haddasah”).
The primary aim of the clinical trial was to determine the
safety profile and tolerability of . In addition, effects on,
mortality, organ dysfunction and number of hospitalization days in
general and in the intensive care unit (ICU) were measured.
MortalityThe Acute Physiology and Chronic
Health Evaluation (APACHEII) score of the Allocetra OTS-treated
group was 12.3, and the corresponding probability of mortality of
at least one patient in that group was predicted at 85% based on
the hospital’s ICU staff’s clinical assessment of each patient’s
overall condition at admission. However, none (0%) of the
Allocetra-OTS-treated patients died during the 28-day study period,
as compared to 27% 28-day mortality in the matched controls
group.
Sepsis & Organ FailureEach of the 10
Allocetra-OTS-treated patients had between 2 to 5 dysfunctional
organ systems upon admission to the ICU. All (100%) of the
Allocetra-OTS-treated patients had rapid and complete recovery from
their septic conditions and of any organ dysfunction that was
present upon admission to the ICU. Despite the similarity of
organ-failure state (SOFA) at entry between the
Allocetra-OTS-treated patients and the matched controls group
(average of 3.4 versus 3.47), not a single patient treated with
Allocetra-OTS had any increase in organ-failure state post
administration of Allocetra-OTS, while the majority of the patients
in the matched controls group had an increase in organ-failure
state. The average worsening in organ-failure state of patients in
the matched controls group was approximately 100% compared with
their ICU hospitalization state vs zero (0%) percent worsening in
organ-failure state of Allocetra-OTS-treated patients post
administration of Allocetra-OTS (p< <0.0001).
Duration of ICU HospitalizationThe ICU
length-of-stay for all Allocetra-OTS-treated patients was
significantly shorter than those patients who received only the
standard of care, with an average of 4 days compared to 11.11 in
the matched controls group, a 64% reduction (p<0.0001). The
slowest ICU discharge of a patient treated with Allocetra-OTS was
after 8 days, while approximately 50% of the matched controls group
were still at the ICU after 28 days.
SafetyAllocetra-OTS was shown to be safe and
tolerable, with no serious unexpected severe adverse reactions and
no serious adverse events.
Prof. Dror Mevorach, Chief Medical Officer of Enlivex,
commented, “We were excited to observe such deep and durable
responses at a well-tolerated dose in this highly fragile and
extremely difficult to treat septic population, and obtaining
statistically-significant differences from the matched historical
controls group. We believe that Allocetra-OTS is positioned as a
potentially clinically viable option for treatment of sepsis, which
is a clinical condition that has poor clinical outcomes and no
currently effective therapy.”
Oren Hershkovitz, CEO of Enlivex, stated, “Allocetra-OTS is a
significant product candidate for Enlivex, and the robust results
of this study are highly encouraging. We are compiling patient’s
cytokine storm data in an effort to analyze the potential of
Allocetra-OTS in other clinical indications whose pathophysiology
is highly correlated with cytokine storms and exaggerated immune
responses.”
Study designThe aim of this study was to
determine the safety and efficacy profile and tolerability of
Allocetra-OTS, in subjects admitted to the emergency room with
sepsis. Allocetra-OTS (140x106 cells/kg) was administered in either
a single dose to 6 patients at day 1 or in two doses to 4
additional patients at days 1 and 3, to patients admitted to the
emergency room with sepsis. Patients were followed for 28 days. The
study subjects were also compared to historical controls
hospitalized in the ICU, matched by age, gender, Sequential Organ
Failure Assessment (SOFA) score, and infection source.
Sepsis is defined as a life-threatening organ dysfunction caused
by a dysregulated immune response to infection. Sepsis has been
identified by the World Health Organization as a global health
priority and currently has no FDA-approved pharmacologic treatment.
Sepsis is the third leading cause of mortality in the United States
after cardiovascular and cancer diseases and affects approximately
1.7 million adults in the United States each year. Various studies
have estimated that up to 50% of severe sepsis hospitalizations
culminate in death.
AllocetraTM is an experimental therapy
being investigated for treatment of patients with organ failure
associated with sepsis, a syndrome whose lethal pathophysiology –
hyper stimulation of the immune response and cytokine storm
followed by organ failure – that may be similar to that of the
coronavirus (COVID-19) associated with the newly recognized virus
SARS-CoV-2.
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 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.
ENLIVEX CONTACT:
Shachar Shlosberger, CFO
Enlivex Therapeutics,
Ltd.
shachar@enlivexpharm.com
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