Enlivex Therapeutics Announces Positive Interim Safety and Efficacy Data From Ongoing Trial of Off-The-Shelf Allocetra in Pat...
November 04 2019 - 6:30AM
Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage
immunotherapy company, today announced positive interim efficacy
data from the Company’s ongoing Phase Ib clinical trial in patients
with severe sepsis. The interim analysis is based on a dataset of
43 patients with severe sepsis, all hospitalized at Hadassah
Medical Center, which is one of the largest and most prestigious
hospitals in Israel. Six patients admitted to Hadassah’s intensive
care unit with sepsis have been administered with off-the-shelf
Allocetra (“OTS Allocetra”) upon their admission, while 37 patients
were matched controls that received standard of care treatment
during 2016-2019 but did not receive OTS Allocetra.
The primary safety parameter was 28 days mortality. None (0 of
6) of the OTS Allocetra -treated patients died during this period,
compared to 11 of 37 (29%) in the matched control group who died
during this period. OTS Allocetra treatment resulted in improved
efficacy in all analyzed parameters, which included the sequential
organ failure assessment (SOFA) score (the higher the score, the
worse the clinical condition of various organs), as well as
recovery from sepsis, number of days of hospitalization in the
intensive care unit, and others. The interim and efficacy data are
as follows:
Sepsis Outcomes |
Matched Untreated Group |
OTS Allocetra Treated Group |
|
|
|
- % of patients that recovered from sepsis within 28 days
|
Significant increase in recovery from sepsis in patients
that were treated with Allocetra-OTS |
48 |
% |
100 |
% |
|
29 |
% |
0 |
% |
- Average organ failure score (SOFA) at admission vs maximal
reached during hospitalization
|
OTS Allocetra substantially prevents organ failure in
severe sepsis patients |
Avg. at admission: 3.98 Avg. maximal: 8.11 |
Avg. at admission: 4.5 Avg. maximal: 4.5 |
- Median organ failure score (SOFA) at admission vs maximal
reached during hospitalization
|
Median at admission: 4 Median maximal: 8 |
Median at admission: 4.5 Median maximal: 4.5 |
- % of patients with organ failure score (SOFA) that increased
during 28-day period
|
SOFA increase is associated with organ dysfunction and
failure, and was prevented in patients treated with OTS
Allocetra |
78 |
% |
0 |
% |
- % of patients with organ failure score (SOFA) that increased by
4 or more points during 28 days
|
SOFA increase => 4 is associated with high probability
of mortality, and was prevented in patients treated with OTS
Allocetra |
57 |
% |
0 |
% |
- % of patient mortality among those with organ failure score
(SOFA) that increased by 4 or more during 28 days
|
52 |
% |
0 |
% |
- % of patients still in the intensive care unit after 6
days
|
57 |
% |
0 |
% |
Prof. Dror Mevorach, Chief Medical Officer of Enlivex,
commented, “We are pleased with the robust safety and efficacy
profile demonstrated by OTS Allocetra in the interim analysis of
patients with severe sepsis. Even in a small group of patients,
some of the efficacy parameters are already
statistically-significant. Our previous analysis showed that no
serious adverse events were associated with OTS Allocetra in these
patients. Together with our preclinical data, as well as human data
from a Phase IIa clinical trial relating to the prevention of GvHD,
we believe that OTS Allocetra 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.”
Shai Novik, Chairman of Enlivex, stated, “We are encouraged by
these interim safety and efficacy analysis results. OTS Allocetra
is a significant product candidate for Enlivex, and we look forward
to obtaining additional clinical data. We hope to complete the
ongoing study by the end of 2019 and provide a final efficacy data
analysis shortly thereafter.”
The matching of the 37 patients to the OTS Allocetra-treated
group was based on similar organ failure clinical SOFA score at
admission, overall clinical state, age group, sex, and source of
severe sepsis (pneumonia, endovascular, or urinal tract
infections). All matched patients were treated at the same hospital
as the Allocetra-treated group.
Matching Characteristics |
Matched Untreated Group |
Treated With OTS Allocetra |
|
|
|
|
67% |
68% |
- Endovascular infection (MRSA)
|
16% |
17% |
|
17% |
15% |
|
Avg. age: 69.2 Median age: 69.0 |
Avg. age: 69.8 Median age: 70.5 |
- SOFA at admission (average & median)
|
Avg. at admission: 3.98 Median at admission: 4 |
Avg. at admission: 4.50 Median at admission: 4.50 |
|
All male |
All male |
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.
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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