- The $1.5 million award is to evaluate the ability of NervGen’s NVG-291-R to accelerate and enhance restoration of function following peripheral nerve injury (PNI)
- The research is to support a potential game changing therapeutic approach to restore function for US military service members and the estimated 20+ million Americans suffering from PNI
- There are currently no effective regenerative pharmaceuticals to enhance recovery in PNI
Vancouver, Canada. October 12, 2022 – NervGen Pharma Corp. (TSX-V: NGEN) (OTCQX: NGENF) (“NervGen” or the “Company”), a clinical stage biotech company dedicated to developing innovative solutions for the repair of nervous system damage, today announced it has been awarded up to US$1.5 million in US Department of Defense (DoD) funding from the Military Operational Medicine Research Program (MOMRP/JPC-5) to evaluate NervGen’s NVG-291-R as a therapeutic to enable accelerated and enhanced restoration of function following peripheral nerve injury. The work described in the project would establish preclinical proof-of-concept for the use of NVG-291-R to improve the rate and extent of nerve regeneration following peripheral nerve crush injury or transection followed by repair. There are currently no effective pharmaceutical treatments to enhance recovery in PNI. The funding was made through the US Army Medical Research and Development Command’s (USAMRDC) Other Transaction Agreement with the Medical Technology Enterprise Consortium (MTEC). MTEC is an enterprise partnership in collaboration with industry and academia to facilitate research and development activities in cooperation with the DoD and other government agencies in the biomedical sciences.
“We very much appreciate the support of the US DoD’s Medical Technology Enterprise Consortium and look forward to conducting further research in PNI,” stated Bill Radvak, NervGen’s Executive Chairman and Interim CEO. “The existing preclinical data with NVG-291-R in nerve root crush models strongly support the proposed, more detailed investigation with NVG-291-R in PNI. Given that our core indications of spinal cord injury, Alzheimer’s disease and multiple sclerosis relate to central nervous system conditions, this is a great opportunity to conduct further preclinical research into NVG-291’s ability to repair damage after injury to the peripheral nervous system. In addition to US military service members, it is estimated that over 20 million Americans suffer from some form of PNI, which represents a potentially attractive commercial development opportunity for NervGen. Our hope is that the funding of this research represents the first of many collaborations between the DoD, government agencies, academia, and NervGen to investigate the potential of NVG-291 to improve function following traumatic injury of the peripheral and central nervous systems.”
NervGen will be working with Wilson “Zack” Ray, MD, a Professor of Neurosurgery, Orthopedic Surgery, and Biomedical Engineering at Washington University in St. Louis, to evaluate the investigational therapeutic NVG-291-R.
“Lack of regeneration or slow regeneration rates are major contributors to potentially chronic sensory and motor deficits following a peripheral nerve injury,” said Dr. Ray. “If regrowth and reinnervation do not occur within 12 to 18 months, sensation and/or motion can be permanently lost with little chance for a functional recovery. NVG-291-R may enhance the recovery rate following PNI through several mechanisms: by promoting regeneration of injured axons through the injury; by increasing the rate of regeneration and shortening the time to recovery; by encouraging healthier connections once reinnervation does occur; and by enhancing plasticity in the central nervous system (CNS) to remap neural networks.”
Dr. Michael Davis, MD, FACS, FRCS (Hon.), USAF Colonel (Ret.), former Director of the US Department of Defense’s Combat Casualty Care Research Program and consultant to NervGen stated, “This is a very important development for the Warfighter. Combat-sustained PNI (CSPNI) have increased in frequency and severity among US forces engaged in contemporary warfare and contribute significantly to the burden of combat injury. Blast injuries have accounted for up to 78% of the casualties from recent conflicts in Iraq and Afghanistan and are frequently associated with PNI along with ballistic and shrapnel injuries. Only 9% of Warfighters with CSPNI treated with the current standard of care were able to return to full military duty. There are no effective regenerative treatments to enhance recovery in PNI in either low or high nerve injuries. NVG-291 has the potential to be used to treat PNI of all severities in both acute and chronic settings to promote repair and restore function. In my view, there has never been a pharmacologic therapy that holds such promise in promoting restoration of function after nerve injury.”
The objectives of the research program are: (i) to investigate functional and histological recovery following treatment with NVG-291-R in different animal models of PNI, (ii) to identify the best dosing regimen for NVG-291-R to advance to a clinical study in patients with PNI, and (iii) to identify where NVG-291-R may be exerting therapeutic benefits (e.g., enhancing regeneration through lesion, rate of regeneration, remyelination of axons, plasticity in CNS).
The views expressed in this news release are those of the Company and its collaborators and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.
About U.S. Army Medical Research and Development Command
The USAMRDC is the Army’s medical materiel developer, with responsibility for medical research, development, and acquisition. USAMRDC produces medical solutions for the battlefield with a focus on various areas of biomedical research, including military infectious diseases, combat casualty care, military operational medicine, medical chemical and biological defense. To find out more about USAMRDC, visit https://mrdc.amedd.army.mil/.
About Medical Technology Enterprise Consortium
MTEC is a 501(c)(3) biomedical technology consortium that is internationally-dispersed, collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement with the U.S. Army Medical Research and Development Command. The consortium focuses on the development of medical solutions that protect, treat, and optimize the health and performance of U.S. military personnel and civilians. To find out more about MTEC, visit https://www.mtec-sc.org/.
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.
For further information, please contact:
Huitt Tracey, Corporate Communications
htracey@nervgen.com
604.537.2094
Nancy Thompson, Vorticom Public Relations
nancyt@vorticom.com
212.532.2208
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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 total funding amount and research objectives of the award; the design of the planned preclinical studies with Washington University; the potential mechanisms by which NVG-291-R may enhance recovery following PNI; our belief that the existing preclinical data with NVG-291-R strongly support the proposed, more detailed investigation in PNI; the importance of non-dilutive funding to our development programs; the incidence and prevalence of PNI and the size of the commercial opportunity; the prospects for receiving future awards and collaborations; the importance and promise of this development for the treatment of CSPNI in the Warfighter; the Company’s target indications; and the development of innovative treatments that enable the nervous system to repair itself.
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, Short Form Base Shelf Prospectus, 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.
