- The independent peer-reviewed study showed improved memory as
well as motor and sensory functions in rodents when treatment with
NVG-291-R began 7 days after stroke onset
- There is currently no FDA-approved drug for the repair of
damage from a stroke
- NVG-291, currently in a Phase 1 clinical trial in healthy human
subjects, could provide a completely new treatment paradigm for
stroke patients
NervGen Pharma Corp., (TSX-V: NGEN) (OTCQX: NGENF), is
pleased to announce the University of Cincinnati and Case Western
Reserve University (CWRU) have published a pioneering preclinical
study in the peer-reviewed scientific journal Cell Reports
demonstrating that NervGen’s proprietary drug, NVG-291-R, promotes
nervous system repair and significant functional recovery in a
mouse model of severe ischemic stroke, even when treatment was
initiated up to 7 days after onset. Currently there are no United
States Food and Drug Administration (FDA) approved drugs that
repair damage from a stroke. NervGen holds the exclusive worldwide
rights to NVG-291, which is currently in a Phase 1 clinical trial
in healthy human subjects and is preparing to initiate Phase 1b/2
clinical trials for the repair of nervous system damage from spinal
cord injury, Alzheimer’s disease and multiple sclerosis.
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the full release here:
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Dr. Agnes (Yu) Luo, Associate Professor,
Department of Molecular Genetics and Biochemistry at the University
of Cincinnati, Senior Author of the Cell Reports paper. (Photo:
Business Wire)
“We are very excited about the data showing significant
improvement in motor function, sensory function, spatial learning,
and memory, even when treatment was initiated as late as 7 days
after stroke onset,” stated the senior author of the paper, Dr.
Agnes (Yu) Luo, Associate Professor, Department of Molecular
Genetics and Biochemistry at the University of Cincinnati.
“If these results translate to the clinic, NVG-291 would be a
substantial breakthrough in the treatment of stroke patients for
multiple reasons because the only current FDA-approved drug for
treatment of stroke does not repair damage and must be administered
within 4.5 hours of stroke onset.” Dr. Luo continued, “Most
therapies being researched today primarily focus on reducing the
early damage from stroke. However, we have shown that treatment
with NVG-291-R not only results in neuroprotection to reduce
neuronal death but also robust neuroreparative effects. Also,
importantly, most therapies being researched need to be applied
within 24 to 48 hours of a stroke’s onset; in contrast, our
preclinical data shows that treatment with NVG-291-R is effective
even if applied as late as 7 days after the stroke’s onset.”
“This is another remarkable demonstration of NVG-291’s potential
to repair damage to the nervous system,” stated Dr. Jerry Silver,
Professor of Neurosciences at CWRU’s School of Medicine, co-author
of the Cell Reports paper, and inventor of NervGen’s technology.
“In these studies, we demonstrated that NVG-291-R repaired damage
using at least two modes of repair: first by substantially
increasing plasticity resulting in the creation of new neuronal
connections, and second by enhanced migration of newly born neurons
derived from neuronal stem cells to the site of damage. NVG-291-R’s
ability to enhance plasticity was demonstrated by using staining
techniques that clearly showed an increase in axonal sprouting to
the damaged part of the brain. This enhanced plasticity is an
excellent validation of the same powerful mechanisms that we and
other researchers were able to demonstrate using NVG-291-R in
spinal cord injury.”
“The fact that NVG-291-R showed an effect in an animal model
seven days after the onset of stroke is very encouraging,” stated
Dr. S. Claiborne Johnston, a leading specialist in stroke care and
research, formerly the inaugural Dean at Dell Medical School and
now a professor in the Department of Neurology at Dell Medical
School at The University of Texas at Austin. “An agent that works
this late and through this mechanism could be much easier to test
in trials and could ultimately help many more stroke patients than
current therapies.”
“Most therapies in development for stroke focus on minimizing
the extent of initial damage from a stroke, which means that to be
effective they must be administered within the first hours after
symptom onset,” continued Dr. Johnston. “Most patients don’t arrive
soon enough to benefit from the few drugs we have, whether in
current practice or those we are testing in clinical trials. A long
treatment window will make recruitment easier and faster for future
clinical trials.”
“This is a very important development for NervGen as, for the
first time in a peer-reviewed publication, NVG-291-R demonstrated
improvements in memory and spatial learning which may be relevant
for other indications affecting cognition, such as Alzheimer’s
disease, where it might improve cognition rather than simply
slowing cognitive decline,” stated Paul Brennan, NervGen’s
President & CEO. Mr. Brennan continued, “While we remain
committed to developing NVG-291 in our core indications of spinal
cord injury, Alzheimer’s and multiple sclerosis, this paper
provides a very strong argument to undertake a stroke study with
NVG-291. Given this compelling new preclinical data, we believe
there is a solid opportunity to secure non-dilutive funding to
advance the program through a partnership, either with industry or
government.”
The full article on the study of NVG-291-R in ischemic stroke is
available online in Cell Reports in the article entitled
“Inhibition of CSPG receptor PTPσ promotes migration of newly born
neuroblasts, axonal sprouting and recovery from stroke”.
About NervGen
NervGen (TSX-V: NGEN, OTCQX: NGENF) is a clinical stage biotech
company dedicated to developing innovative treatments that enable
the nervous system to repair itself following damage, whether due
to injury or disease. NervGen’s lead drug candidate, NVG-291, is
currently in a Phase 1 clinical trial. The company’s initial target
indications are spinal cord injury, Alzheimer’s disease and
multiple sclerosis. For more information, go to
www.nervgen.com.
About NVG-291
NervGen holds the exclusive worldwide rights to NVG-291 and is
developing a unique new class of drugs around the technology.
NVG-291 is a therapeutic peptide that mimics the intracellular
domain of the receptor protein tyrosine phosphatase sigma (PTPσ), a
cell surface receptor known to interact with chondroitin sulfate
proteoglycans (CSPGs). Both PTPσ and CSPGs have been shown to
inhibit neural repair mechanisms following nervous system damage.
NVG-291-R, the rodent form of NVG-291, has been shown to promote
functional recovery and enable nervous system repair in a range of
animal models, including models of spinal cord injury, peripheral
nerve injury, multiple sclerosis and stroke, through enhanced
plasticity, axonal regeneration, and remyelination.
About Stroke
Stroke is a disease that affects the blood vessels leading to
and within the brain. A stroke occurs when a blood vessel that
carries oxygen and nutrients to the brain is either blocked by a
clot or bursts (or ruptures). When that happens, part of the brain
cannot get the blood (and oxygen) it needs, such that brain cells
in that area die. A stroke can cause lasting brain damage,
long-term disability, or even death.
According to the U.S. Center for Diseases, Control and
Prevention (CDC), every year more than 795,000 people in the United
States have a stroke. Approximately 610,000 of these are first or
new strokes, and 185,000 strokes are in people who have had a
previous stroke. Stroke is a leading cause of serious long-term
disability and reduces mobility in more than half of stroke
survivors aged 65 and over. Stroke-related costs in the United
States came to nearly $46 billion between 2014 and 2015, which
includes the cost of health care services, medicines to treat
stroke, and missed days of work.
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Cautionary Note Regarding Forward-Looking Statements
This news release may contain “forward-looking information” and
“forward-looking statements” within the meaning of applicable
Canadian and United States securities legislation. Such
forward-looking statements and information herein include, but are
not limited to, the Company’s current and future plans,
expectations and intentions, results, levels of activity,
performance, goals or achievements, or any other future events or
developments constitute forward-looking statements, and the words
“may”, “will”, “would”, “should”, “could”, “expect”, “plan”,
“intend”, “trend”, “indication”, “anticipate”, “believe”,
“estimate”, “predict”, “likely” or “potential”, or the negative or
other variations of these words or other comparable words or
phrases, are intended to identify forward-looking statements.
Forward-looking statements include, without limitation, statements
relating to: the timing, objectives and study design of the
clinical development of NVG-291, including the planned Phase 2
clinical trials in multiple indications and the ongoing Phase 1
study in healthy volunteers; our development of a unique new class
of drugs around the technology of NVG-291; our belief that if these
results translate from animals to human trials, that NVG-291 could
revolutionize clinical trials in stroke and will be a substantial
breakthrough in a completely new treatment paradigm for stroke
patients; the results in the stroke study are an excellent
validation of the same powerful mechanisms demonstrated using
NVG-291-R in spinal cord injury; the mechanism of NVG-291 could be
much easier to test in trials and could ultimately help many more
stroke patients than current therapies; a long treatment window
will make recruitment easier and faster for future clinical trials;
our belief that there is a very strong argument to undertake a
Phase 2 stroke study with NVG-291 and provide a solid opportunity
to seek non-dilutive funding to support our development of NVG-291
in stroke; the Phase 1 results reported to date; our confidence
that the results shown in this study may be relevant for other
indications that affect cognition; the timing and requirements to
remove the partial clinical hold initiated by the FDA; the clinical
development of NVG-291 for Alzheimer’s disease, multiple sclerosis
and spinal cord injury; the belief that inhibiting the activity of
PTPσ is a promising target for reducing the clinical effects of
nervous system damage through multiple mechanisms; the estimates of
the incidence and prevalence of stroke in the United States; and
the creation of innovative treatments of nervous system damage due
to injury or disease.
Forward-looking statements are based on estimates and
assumptions made by the Company in light of management’s experience
and perception of historical trends, current conditions and
expected future developments, as well as other factors that we
believe are appropriate and reasonable in the circumstances. In
making forward-looking statements, the Company has relied on
various assumptions, including, but not limited to: the Company’s
ability to manage the effects of the COVID-19 pandemic; the
accuracy of the Company’s financial projections; the Company
obtaining positive results in its clinical and other trials; the
Company obtaining necessary regulatory approvals; and general
business, market and economic conditions.
Many factors could cause our actual results, level of activity,
performance or achievements or future events or developments to
differ materially from those expressed or implied by the
forward-looking statements, including without limitation, a lack of
revenue, insufficient funding, the impact of the COVID-19 pandemic,
reliance upon key personnel, the uncertainty of the clinical
development process, competition, and other factors set forth in
the “Risk Factors” section of the Company’s Annual Information
Form, Prospectus Supplement, financial statements and Management
Discussion and Analysis which can be found on SEDAR.com. All
clinical development plans are subject to additional funding.
Readers should not place undue reliance on forward-looking
statements made in this news release. Furthermore, unless otherwise
stated, the forward-looking statements contained in this news
release are made as of the date of this news release, and we have
no intention and undertake no obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by applicable law.
The forward-looking statements contained in this news release are
expressly qualified by this cautionary statement.
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version on businesswire.com: https://www.businesswire.com/news/home/20220727006174/en/
Huitt Tracey, Corporate Communications htracey@nervgen.com
604.362.6209 Nancy Thompson, Vorticom Public Relations
nancyt@vorticom.com 212.532.2208 Follow NervGen on Twitter,
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