Enlivex Therapeutics Completes Recruitment In Phase Ib Trial Evaluating Safety And Efficacy Of Universal Off-The-Shelf Alloce...
November 18 2019 - 8:30AM
Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage
immunotherapy company, today reported completion of patient
recruitment into the Company’s Phase Ib clinical trial in patients
with severe sepsis. The study was designed to recruit ten patients,
including six treated with a single dose of Allocetra, and four
patients treated with two doses of Allocetra.
Enlivex announced on November 4, 2019 positive interim safety
and efficacy data from an ongoing trial of off-the-shelf universal
Allocetra in patients with severe sepsis. The interim analysis
comparing the first six Allocetra-treated patients with 37 severe
sepsis patients with equivalent source of infection and disease
severity who were hospitalized at the same hospital, demonstrated
the potential of single dose Allocetra infusion as therapy for
prevention of sepsis-associated organ failure and mortality.
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 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 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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