Preclinical Data Indicating Allocetra-OTS As Potential Therapy For Prevention Of Organ Failure And Mortality Associated with ...
October 10 2019 - 7:30AM
Enlivex Therapeutics Ltd. (Nasdaq:ENLV), a clinical-stage
immunotherapy company, today announced today that the European and
Int'l Shock Societies selected, for an oral presentation,
“Pathogen- and damage-associated molecular patterns are immune
modified by apoptotic cell adjuvant therapy for acute sepsis in a
cecal ligation and puncture mice model, and avoids multi-organ
failure and improves survival” to be presented at the XVIIIth
Congress of the European Shock Society and IXth Congress of the
Int'l Federation of Shock Societies, on October 11, 2019, 11:40am,
held at the Avra Imperial Hotel & Conference Center, Chania,
Crete, Greece.
The presentation details results of preclinical studies, which
were designed to evaluate the effect of Allocetra-OTS immunotherapy
on subjects with highly-severe sepsis. The data showed ten-fold
(10x) increased survival for study subjects who were treated with
Allocetra-OTS therapy and antibiotics and fluids, as compared to
subjects treated solely with antibiotics and fluids. Specifically,
the levels of cytokine storms and organ failures were dramatically
lower in the Allocetra-OTS group, leading to improved survival.
“Enlivex previously reported positive interim safety and
tolerability of Allocetra-OTS in six patients with severe sepsis as
part of an ongoing Phase Ib clinical trial. These interim safety
results, taken together with the efficacy profile of improved
survival and reduced cytokine storms and organ damage, present
Allocetra-OTS as a potential candidate to become the first therapy
ever to be approved for severe sepsis,” stated Dror Mevorach, M.D.,
Chief Scientific and Medical Officer of Enlivex.
The XVIIIth Congress of the European Shock Society and IXth
Congress of the Int'l Federation of Shock Societies is focused on
hot topic key notes provided by world-known experts. Current
topics with focus on trauma/hemorrhagic shock/sepsis discussed
during the conference include immune and organ responses, novel
pathways, trauma modelling, comorbidities, novel therapies, long
term effects, precision modeling, international shock research.
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 ENLIVEXEnlivex 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.
ABOUT THE EUROPEAN SHOCK SOCIETY
The primary objective of the European Shock
Society is to advance understanding of the pathophysiology and to
improve treatment of shock, trauma and sepsis and/or allied
disciplines. For more information, visit
https://www.europeanshocksociety.org/
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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