- Phase 1b/2a trial of NervGen’s lead compound, NVG-291, is based
upon unprecedented, peer-reviewed animal studies demonstrating
pronounced functional recovery from spinal cord injury
- “The ability of NVG-291 to demonstrate meaningful recovery in
motor function, sensory function and bladder control in animal
models is exceptional. If these results translate to patients,
NVG-291 could redefine the treatment of spinal cord injury.” - Dr.
Monica Perez, Shirley Ryan AbilityLab
- NervGen plans to include acute/subacute and chronic spinal cord
injury patients in its clinical trial
NervGen Pharma Corp., (TSX-V: NGEN) (OTCQX: NGENF)
(“NervGen” or the “Company”), a clinical stage biotech company
dedicated to creating innovative treatments for nervous system
damage, is pleased to announce it has entered into a Memorandum of
Understanding with Shirley Ryan AbilityLab with the intention of
performing NervGen’s first clinical trial with the Company’s
proprietary NVG-291 in spinal cord injury (SCI) patients. The
single site clinical trial, which is expected to start in the
second half of 2022, will be a placebo-controlled trial, assessing
the safety and efficacy of NVG-291 in treating acute/subacute
(<3 months post-injury) and chronic (≥1 year post-injury)
patients. In two independent animal studies published in Nature and
Experimental Neurology, NVG-291 treatment resulted in significant
recovery in mobility and/or bladder function, despite experiencing
a debilitating spinal cord injury.
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Dr. Jerry Silver is Professor of
Neurosciences at Case Western Reserve University’s School of
Medicine and adjunct Professor in the Department of Neurosurgery at
the Cleveland Clinic Foundation. He is credited in over 180
publications and is the recipient of several prestigious awards,
including the Ameritec Prize for significant accomplishments toward
a cure for paralysis. In 2003 he was also honored with the
Christopher Reeve-Joan Irvine Research Medal (The Reeve-Irvine
Medal) for critical contributions that may lead to the promotion of
repair of the damaged spinal cord. Dr. Silver is an active advisor
to NervGen, and his lab continues to conduct studies in concert
with other academic institutions and partners to advance and evolve
intracellular sigma peptide.
NVG-291 is based on the groundbreaking discovery by Dr. Jerry
Silver at Case Western Reserve University of a class of molecules
(chondroitin sulfate proteoglycans, or CSPGs) that are upregulated
in response to nervous system damage and that inhibit repair.
NVG-291 was designed to bypass this inhibition by CSPGs, thereby
enhancing the body’s natural repair mechanisms, including
plasticity, regeneration and remyelination.
“We have been following Dr. Silver’s work for years and are very
excited to be the first center working with NervGen on this
important spinal cord injury study,” stated Monica A. Perez, PT,
PhD, Scientific Chair of the Arms + Hands Lab at Shirley Ryan
AbilityLab; Professor of Physical Medicine & Rehabilitation at
Northwestern University; and Research Scientist at the Edward Hines
Jr. VA Hospital. “One of the important aspects of this
single-center, placebo-controlled trial is the use of advanced
electrophysiology to assess transmission in cortical and
subcortical neuronal pathways as well as behavioral outcomes. The
ability of NVG-291 to demonstrate meaningful recovery in motor
function, sensory function and bladder control in animal models is
exceptional. If these results translate to patients, NVG-291 could
redefine the treatment of spinal cord injury.”
“NervGen and Shirley Ryan AbilityLab are planning a very unique
and intriguing trial design, into which I have been fortunate to
provide input,” stated James Guest, MD, PhD, FACS, Professor of
Neurological Surgery at the University of Miami and member of
NervGen’s Spinal Cord Injury Clinical Advisory Board. “The
rationale to include acute and chronic patients in a study
underscores the broad potential of the mechanism of NVG-291 in SCI.
Using Shirley Ryan AbilityLab in a single-center study that
implements advanced electrophysiological techniques to monitor
connectivity across the site of injury will allow reproducible
testing to explore NVG-291’s effects on motor recovery, possibly
shaping the impact of subsequent studies. Partnering with Shirley
Ryan AbilityLab, a leading institution in spinal cord injury
research and management of patients with spinal cord injury, is an
exceptional opportunity for NervGen.”
“NervGen is excited to be working towards executing this
important clinical trial for spinal cord injury patients,” stated
Paul Brennan, NervGen’s President & CEO. “The unprecedented
preclinical results utilizing NVG-291 that were published by Dr.
Silver and others gave the spinal cord injury community a real
reason for hope. With these patients in mind, NervGen’s team has
worked diligently since its inception to advance this technology
into the clinic with the goal of bringing NVG-291 to patients as
quickly as possible. Our recent interim data from the single
ascending dose (SAD) portion of our Phase 1 clinical study was very
encouraging and we’re looking forward to completing this study in
the first half of 2022. In addition to initiating this important
clinical trial in spinal cord injury, the Company plans to leverage
the same powerful mechanism of action demonstrated by NVG-291 to
conduct studies by the end of 2022 for the treatment of both
Alzheimer’s disease and multiple sclerosis patients.”
NervGen is currently conducting a Phase 1 clinical trial in
healthy volunteers and recently reported on the results of the SAD
portion of the study. The Company has received safety review
committee and ethics committee approval to proceed to the multiple
ascending dose (MAD) portion of the study where subjects will be
dosed in a blinded fashion with NVG-291 or placebo once a day for
14 consecutive days. Following completion of ongoing toxicology
studies requested by the United States Food and Drug Administration
(FDA), and provision of available data from the ongoing Phase 1
study to the FDA, NervGen will seek removal of the partial clinical
trial hold initiated by the FDA and evaluate the safety and
pharmacokinetics of NVG-291 in cohorts of healthy males and healthy
premenopausal females, separate from the SCI study announced in
this press release. Following completion of the Phase 1 study in
healthy males and the premonopausal females, NervGen intends to
proceed to the planned Phase 1b/2 safety and efficacy studies in
spinal cord injury, multiple sclerosis, and Alzheimer’s disease
patients.
About NervGen
NervGen is restoring life’s potential by creating innovative
treatments of nervous system damage due to injury or disease. The
Company is initially developing treatments for multiple sclerosis,
spinal cord injury and Alzheimer’s disease. For more information,
go to www.nervgen.com.
About Shirley Ryan AbilityLab
Shirley Ryan AbilityLab, formerly the Rehabilitation Institute
of Chicago, is a global leader in physical medicine and
rehabilitation for adults and children with the most severe,
complex conditions ranging from traumatic brain and spinal cord
injury to stroke, amputation, and cancer-related impairment. The
organization expands and accelerates leadership in the field that
began at the Rehabilitation Institute of Chicago in 1953. The
quality of its care and research has led to the designation of the
“No. 1 Rehabilitation Hospital in America” by U.S. News & World
Report every year since 1991. Upon opening in March 2017, the $550
million, 1.2 million square foot Shirley Ryan AbilityLab became the
first-ever translational research hospital in which clinicians,
scientists, innovators, and technologists work together in the same
space, surrounding patients, discovering new approaches and
applying (or “translating”) research in real time. This unique
model enables patients to have 24/7 access to the brightest minds,
the latest research, and the best opportunity for recovery. For
more information, go to www.sralab.org.
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 which is a mimetic of the
intracellular domain of protein tyrosine phosphatase (PTPσ), a cell
surface receptor known to interact with chondroitin sulfate
proteoglycans (CSPGs) and to be involved in the regulation of
neuroplasticity and central nervous system repair. In preclinical
studies, NVG-291 has demonstrated the potential to promote repair
mechanisms in the nervous system, including axonal regeneration,
remyelination, and enhanced plasticity. The demonstration of repair
via these mechanisms in animal models of nervous system injury has
been accompanied by recovery of multiple neurological functions,
including motor, sensory, autonomic and cognitive functions.
NVG-291 has shown efficacy in a range of animal models, including
models of nervous system trauma (e.g. spinal cord injury,
peripheral nerve injury) and disease (multiple sclerosis,
stroke).
About Spinal Cord Injury
Spinal cord injury is a devastating condition in which axons and
neurons in the spinal cord are injured or transected. As a result,
the messages to and from the brain cannot get through the injury to
enable movement, perception of sensation, or control of the
autonomic nervous system (for example, bladder control). Symptoms
will depend on injury location and severity and may include
paralysis, breathing difficulty, loss of sensation, bowel, bladder,
and sexual function. Currently, in the US there are no approved
pharmaceutical treatments for spinal cord injury, either to contain
the injury, or in the long term to help the patient recover from
injury.
The most recent estimate of the annual incidence of spinal cord
injury is approximately 54 cases per one million people in the US,
which equals approximately 17,900 new spinal cord injury cases each
year. The estimated number of people with spinal cord injury living
in the US is approximately 296,000 persons, with a range from
252,000 to 373,000 persons.
In the US, average yearly expenses in the first year following
injury range from over $1 million for the most severely injured
patients to $380,000 for less severe injuries. Lifetime costs for a
25-year-old range from approximately $1.7 million to over $5
million.
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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 single site
Phase 1b/2a clinical trial in SCI exclusively with Shirley Ryan
AbilityLab and the ongoing Phase 1 study in healthy volunteers; our
belief that NVG-291 could redefine the treatment of SCI if
preclinical results translate to patients; the potential for the
planned Phase 1b/2a study in SCI to shape the impact of subsequent
studies; our goal of bringing NVG-291 to patients as quickly as
possible; the favorable tolerability and pharmacokinetic profile of
NVG-291; the Phase 1 results reported to date; our confidence that
the efficacy achieved in multiple preclinical disease and injury
models will translate into positive results in our upcoming
clinical trials with patients; 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 SCI in the US and the annual and
lifetime costs of care for SCI patients; 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/20220107005484/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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Nervgen Pharma (TSXV:NGEN)
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부터 10월(10) 2024 으로 11월(11) 2024
Nervgen Pharma (TSXV:NGEN)
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