The crucible of war and caring for injured combat veterans drives innovation in medical science with many innovations that we consider commonplace today born from the brunt of battlefield combat. Consider the World War I veterans who returned home with horrendous facial injuries, who were treated by doctors – now known as plastic or cosmetic surgeons – who restored form and function in wounded soldiers. The next frontier of medicine to help paralyzed soldiers gain mobility and overcome traumatic brain injuries is here and the biotech community is working tirelessly to rise to the challenge and deliver innovations to truly thank these brave men and women for their service.
According to the Centers for Disease Control and Prevention (CDC), “more than 450,000 U.S. service members were diagnosed with a Traumatic Brain Injury (TBI) from 2000 to 2021 and millions more are suffering from the residual effects of less severe TBIs. Spinal Cord Injuries (SCIs) are estimated to affect between 249,000 and 363,000 Americans, with about 17,730 new injuries occurring each year. About 80% of people with new injuries are males, and roughly 42,000 people with SCIs are Veterans,” reports the U.S. Department of Veterans Affairs.
. is working to improve the lives of our veterans and those in active military service recovering from injury. Specifically, our company’s mission is to enable the body’s innate processes, such as neuroplasticity, axonal regeneration and remyelination, to repair damage to the nervous system, including damage from a spinal cord injury (SCI) or a traumatic brain injury (TBI).
Combat-Sustained Traumatic Brain Injury
Dealing with traumatic brain injury is a top priority for the U.S. Department of Defense (DoD) which that almost 400,000 warfighters have suffered from a TBI since 2000 and millions more are suffering from the residual effects of less severe TBIs. Surprisingly 84 percent are non-combat related. And the cost of care is immense with the total lifetime cost estimated at $16 billion for treatment of severe TBIs sustained in Operation Iraqi Freedom and Operation Enduring Freedom.
The field of military medicine is prioritizing treatment for these invisible wounds of war. Any event that delivers a blow or jolt to the head potentially causes a TBI, and, in the military, that blow could come from a myriad of places including explosives, field combat or an accidental fall.
“The brain affects how you think; how you feel; how you act,” the U.S. Department of Veteran Affairs. “So, a TBI can affect your physical functions, thinking abilities, behaviors, and more. The injury can range from mild to severe, and it may increase your risk for mental health conditions such as anxiety and depression, as well as sleeping problems.”
While the majority of TBI injuries among service members come from training and accidents, TBI is one of the signature injuries of troops wounded in Afghanistan and Iraq. A recent, unfortunate example of the prominence of traumatic brain injuries occurred when Iran unexpectedly launched 15 ballistic missiles at the Al Asad Air Base in Iraq in January 2020 in retaliation for a U.S. drone strike that killed Maj. Gen. Qassem Soleimani, a top commander of Iran’s military.
At first it was believed that no one was injured in the missile strike, which narrowly avoided killing scores of U.S. troops. However, weeks later it was revealed that at least 100 soldiers suffered traumatic brain injuries from the attack. These brain injuries weighed heavily on service members, with at least one committing suicide the following year.
U.S. Congress Increases Funding Research in Spinal Cord Injury and Traumatic Brain Injury
Last week, the U.S. Congress passed the final Fiscal Year 2023 Omnibus Appropriations Act that included increased funding for DoD research in spinal cord injury and traumatic brain injury. This funding increase, which NervGen advocated for, helps support the funding mechanisms NervGen hopes to utilize to advance scientific validation of the effectiveness of NervGen’s proprietary lead compound, NVG-291. NervGen’s drug development program modulates the inhibitory effects of chondroitin sulfate proteoglycans (CSPGs), and allows the body’s natural repair mechanisms to occur, including plasticity, axonal regeneration and remyelination.
NervGen worked with several members of Ohio Congressional Delegation to support this funding increase that targets a research program supporting work with the University of Akron studying NVG-291 combined with stem cell therapy to treat SCI and TBI to develop a first-in–class neuroreparative drug to treat nervous system damage.
Obtaining non-dilutive funding is an important strategy for clinical stage biotechnology companies to develop the full potential of their drugs. By actively working with members of Congress, biotech companies can help draw attention to the tremendous potential that their drugs may offer with indications of interest to the U.S. DoD, including peripheral nerve injury, SCI and TBI.
This funding builds on the National Defense Authorization Act for Fiscal Year 2023 (FY23 NDAA), which was recently signed into law by President Joe Biden and also bolsters federal research in this area. In fact, the FY23 NDAA report calls for the DoD to report to Congress on its support for pharmacologic treatments of central nervous system injuries, including TBI and SCI. The full language, which can be found on pg. 259 of the report, reads:
“The committee commends the Department of Defense (DOD) for its continued research and development activities related to treating central nervous system (CNS) injuries sustained by
servicemembers during combat and to the long-term results of injury that may manifest as neurodegenerative diseases. The committee is aware of recent advances in the development of therapeutics designed to repair nervous system damage and to promote brain plasticity that have shown promise for recovery from traumatic brain injury (TBI), spinal cord injury (SCI), and associated neurodegenerative conditions. Therefore, the committee directs the Director of the Defense Health Agency, in coordination with the Assistant Secretary of Defense for Health Affairs, to provide a briefing, not later than March 1, 2023, to the Committees on Armed Services of the Senate and the House of Representatives on the Department’s investments in the development of therapeutics to promote brain plasticity following TBI, SCI, and other nervous system disorders. The briefing shall include, at a minimum, the following:
(1) An assessment of existing and planned investments in TBI and CNS therapeutics and their applicability in promoting brain plasticity;
(2) A strategy that incorporates research, development, procurement, and required regulatory partnerships to expedite delivery of TBI and CNS therapeutics supportive of brain plasticity that can enhance war fighter health and recovery following injury; and
(3) Recommendations for changes to DOD policy or procedures that may be needed to support the delivery of TBI and CNS therapeutics that promote brain plasticity.”
This detailed language, which was supported by Senator Joni Ernst (R-IA), ensures that Congress is kept apprised of the DoD research support for novel therapeutics, like NVG-291. Both measures represent significant steps forward in the Congressional and DoD commitment to the development of therapeutics like NVG-291
Plasticity’s Role in Spinal Cord Injury and Traumatic Brain Injury
The DoD’s supporting language specifically points out the need to support research that relies on plasticity as a major mechanism of action. “Sprouting of the axons from neurons leads to plasticity,” says ,rofessor, Department of Neurosciences, School of Medicine, Case Western Reserve University, and Co-inventor and Advisor at NervGen.
Dr. Silver discovered the novel peptide – NVG-291 modulates the inhibitory effects of CSPGs and has been shown to increase the regeneration rate of the axonal growth cone and enhance plasticity in the central nervous system (CNS) as well as at the neuromuscular junction.
“NVG-291 offers a potential new treatment paradigm by enabling repair of nervous system damage rather than just trying to limit or contain the extent of the damage,” continues Dr. Silver. “The lab has demonstrated that systemic delivery of the peptide has strong efficacy in promoting axonal regeneration and functional recovery in a wide variety of conditions including spinal cord injury where proteoglycans within scar tissue block axonal regeneration.”
The crucible of war and caring for injured combat veterans drives innovation in medical science with many that we consider commonplace today born from the brunt of battlefield combat. Consider the World War I veterans who returned home with horrendous facial injuries, who were treated by doctors – now known as plastic or cosmetic surgeons – who restored form and function in wounded soldiers. The next frontier of medicine to help paralyzed warfighters gain mobility and overcome traumatic brain injuries is here and it’s time for the biotech community to rise to the challenge and deliver innovations to truly thank these brave men and women for their service.