Enlivex Therapeutics Provides Clinical Update on Positive Safety Profile of Its Off-The-Shelf Cell Therapy Product in First T...
June 06 2019 - 6:30AM
Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage
immunotherapy company, today provided a clinical update on the
positive safety profile of its off-the-shelf cell therapy,
AllocetraTM, in the first three severe sepsis patients, as part of
its ongoing Phase Ib clinical trial.
This is the first infusion of off-the-shelf AllocetraTM
(“OTS Allocetra”) in human subjects. Enlivex has developed OTS
Allocetra as a second-generation cell therapy to the matched-donor
Allocetra product, which has demonstrated a robust safety and
clinical efficacy profile in a Phase IIa clinical trial for the
prevention of GvHD in patients following bone-marrow
transplantation. Enlivex designed OTS Allocetra to eliminate the
need to find matched donors as the source of the therapeutic cells
and allow Enlivex to manufacture therapeutic product inventory that
could be used, post regulatory approval, for additional clinical
indications that require swift infusion of the immunotherapeutic
product to patients. The first such indication Enlivex is currently
targeting is prevention of cytokine storms and organ dysfunction
associated with sepsis.
The three patients in the Phase Ib clinical trial of OTS
Allocetra had severe sepsis at the time of OTS Allocetra infusion.
All three patients tolerated the infusion without serious adverse
events. All three patients demonstrated swift clinical improvement
after administration of both the standard-of-care and OTS
Allocetra, and were released from the hospital after the condition
of severe sepsis has been eliminated.
Following the results of the first three patients, Enlivex
obtained regulatory approval for continued recruitment of patients
into the Phase Ib clinical trial.
Prof. Dror Mevorach, Chief Medical Officer of Enlivex,
commented, “We are pleased with the robust safety profile of OTS
Allocetra in the first three sepsis patients in our ongoing Phase
1b clinical trial. Patients with severe sepsis are typically in
highly-fragile clinical states, and it is encouraging that we have
observed no serious adverse events associated with OTS in our
ongoing trial. A potential clinically viable option of an
off-the-shelf formulation could be of great importance for the
commercialization of Allocetra for various clinical indications
without the need to find a matched donor as the source of the
infused cells.”
Shmuel Hess, CEO of Enlivex, stated, “We are encouraged by these
initial results and the regulatory approval for recruitment of
additional sepsis patients. OTS Allocetra is a significant product
for Enlivex, and we look forward to obtaining additional clinical
data”.
The ongoing Phase Ib clinical trial is expected to recruit up to
10 sepsis patients and study the safety and tolerability profile of
OTS Allocetra. Subject to the study results, Enlivex is planning to
initiate a Phase II of OTS Allocetra in up to 40 patients with
sepsis, studying the clinical effect on amelioration of cytokine
storms and prevention of organ dysfunction associated with severe
sepsis.
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”, “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 in Enlivex’s Annual Report on Form 20-F for
the year ended December 31, 2018. 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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