NurExone Biologic Inc. (TSXV: NRX) (Germany: J90) (the
“
Company” or “
NurExone”), a
pioneering biopharmaceutical company, developing regenerative
medicine therapies, is proud to announce a strategic service
agreement with Vivox Ltd. (“Vivox”), a leading provider of animal
testing and services in Israel to biotech and pharmaceutical
companies. This large-scale animal testing represents a significant
step towards filing an Investigational New Drug (IND) application
in the US for NurExone’s ExoPTEN therapy for spinal cord injury
(SCI).
Under the terms of the agreement, Vivox will
provide Contract Research Organization (CRO) services to NurExone,
as a prerequisite to commencing Human Trials under the planned IND.
The scope of the services to be provided includes the carrying out
of experiments by Vivox on a total of 100 rats, divided into 5
different experiments. Every experiment involves comprehensive care
and monitoring of the rats. In the experiments, some of the test
subjects will receive the ExoPTEN active ingredient and a second
group will receive a placebo and/or naïve exosomes (without the
PTEN active ingredient). The typical treatment period is
approximately 2 months. The aim of this series of tests is to
evaluate the optimal dosage of ExoPTEN in various pharmacologically
relevant rodent models of spinal cord. The agreement underscores
both companies' commitment to accelerating innovative therapies for
SCI.
"We are pleased to commission Vivox to conduct a
series of closely monitored experiments on a large group of
laboratory animals as part of the ExoPTEN IND enabling studies. The
testing will encompass mobility, behavior, motor and sensory
recovery of rats following Spinal Cord Injury and treatment with
ExoPTEN," said Dr. Lior Shaltiel, CEO of NurExone. "We anticipate
that this independent and detailed analysis will corroborate and
expand upon the encouraging results observed in numerous laboratory
experiments."
NurExone believes that the ExoPTEN therapy holds
significant promise as a potential treatment for SCI. Preclinical
studies have demonstrated its ability to promote neural
regeneration and functional recovery in animal models. By
collaborating with Vivox, NurExone aims to accelerate the
development and regulatory path of ExoPTEN, to bring this
potentially transformative treatment to patients in need.
About Vivox Ltd.
Vivox is a leading CRO in Israel, specializing
in in-vivo and in-vitro preclinical services for pharmaceutical,
biotech, and medical device companies. Established in 2018, Vivox
has conducted numerous successful experiments and operates a
state-of-the-art facility in Yokne’am-Illit. With a focus on
accuracy and efficiency, Vivox offers a range of services including
toxicology expertise, disease models, surgical services, and
analytics. The company is dedicated to helping pharmaceutical firms
develop innovative medicines through tailored studies conducted
under strict safety measures for high-quality results.
About NurExone Biologic
Inc.
NurExone Biologic Inc. is a TSXV listed
pharmaceutical company that is developing a platform for
biologically-guided exosome-based therapies to be delivered,
non-invasively, to patients who have suffered Central Nervous
System injuries. The Company’s first product, ExoPTEN for acute
spinal cord injury, was proven to recover motor function in 75% of
laboratory rats when administered intranasally. ExoPTEN has been
granted Orphan Drug Designation by the FDA. The NurExone platform
technology is expected to offer novel solutions to drug companies
interested in noninvasive targeted drug delivery for other
indications.
For additional information, please
visit www.nurexone.com or follow NurExone
on LinkedIn, Twitter, Facebook, or YouTube.
For more information, please contact:
Dr. Lior ShaltielChief Executive Officer and
DirectorPhone: +972-52-4803034Email: info@nurexone.com
Thesis Capital Inc.Investment Relation -
CanadaPhone: +1 905-347-5569Email: IR@nurexone.com
Dr. Eva ReuterInvestment Relation -
GermanyPhone: +49-69-1532-5857Email: e.reuter@dr-reuter.eu
Cautionary Statement Regarding
Forward-Looking Statements
This press release contains certain
"forward-looking information" within the meaning of applicable
Canadian securities legislation. Such forward-looking information
and forward-looking statements are not representative of historical
facts or information or current condition, but instead represent
only the Company's beliefs regarding future events, plans or
objectives, many of which, by their nature, are inherently
uncertain and outside of the Company's control. Often, but not
always, forward-looking statements and information can be
identified by the use of words such as "plans", "expects" or "does
not expect", "is expected", "estimates", "intends", "anticipates"
or "does not anticipate", or "believes", or variations of such
words and phrases or state that certain actions, events or results
"may", "could", "would", "might" or "will" be taken, occur or be
achieved.
Forward-looking statements in this news release
include statements relating to: the benefits, terms, and scope of
the strategic agreement, including the stated nature, goals, and
manner of which experiments will be conducted; the ongoing
commitment of the Company to further therapies for SCI; the
anticipation that an independent and detailed analysis will
corroborate and expand upon the encouraging results observed in
numerous laboratory experiments; ExoPTEN therapy holding
significant promise as a potential treatment for SCI; the Company’s
stated goals for accelerating the development and regulatory path
of ExoPTEN; and the expectation of the NurExone platform technology
will offer novel solutions to drug companies interested in
noninvasive targeted drug delivery for other indications.
Forward-looking information in this press
release are based on certain assumptions and expected future
events, namely: the Company’s ability to realize upon the benefits,
terms, and scope of the strategic agreement; the Company’s ability
to keep its ongoing commitment of the Company to further therapies
for SCI; that an independent and detailed analysis will corroborate
and expand upon the encouraging results observed in numerous
laboratory experiments; the ExoPTEN therapy has the ability to be a
significant promise as a potential treatment for SCI; the Company’s
ability to realize upon the stated goals for accelerating the
development and regulatory path of ExoPTEN; and the Company’s
ability to realize upon its expectation of the NurExone platform
technology to offer novel solutions to drug companies interested in
noninvasive targeted drug delivery for other indications.
These statements involve known and unknown
risks, uncertainties and other factors, which may cause actual
results, performance or achievements to differ materially from
those expressed or implied by such statements, including but not
limited to: the Company’s inability to realize upon the benefits,
terms, and scope of the strategic agreement; the Company’s
inability to keep its ongoing commitment of the Company to further
therapies for SCI; that an independent and detailed analysis will
not corroborate and expand upon the encouraging results observed in
numerous laboratory experiments; the ExoPTEN therapy will not be a
significant promise as a potential treatment for SCI; the Company’s
inability to realize upon the stated goals for accelerating the
development and regulatory path of ExoPTEN; and the Company’s
inability to realize upon its expectation of the NurExone platform
technology to offer novel solutions to drug companies interested in
noninvasive targeted drug delivery for other indications.
Readers are cautioned that the foregoing list is
not exhaustive. Readers are further cautioned not to place undue
reliance on forward looking statements, as there can be no
assurance that the plans, intentions or expectations upon which
they are placed will occur. Such information, although considered
reasonable by management at the time of preparation, may prove to
be incorrect and actual results may differ materially from those
anticipated.
Although the Company believes that the
assumptions and factors used in preparing, and the expectations
contained in, the forward-looking information and statements are
reasonable, undue reliance should not be placed on such information
and statements, and no assurance or guarantee can be given that
such forward-looking information and statements will prove to be
accurate, as actual results and future events could differ
materially from those anticipated in such information and
statements.
The forward-looking information and
forward-looking statements contained in this press release are made
as of the date of this press release, and the Company does not
undertake to update any forward-looking information and/or
forward-looking statements that are contained or referenced herein,
except in accordance with applicable securities laws.
Neither TSX-V nor its Regulation Services
Provider (as that term is defined in the policies of the TSX-V)
accepts responsibility for the adequacy or accuracy of this
release.
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