HomeAcute Spinal Cord Injury

Acute Spinal Cord Injury

Traumatic spinal cord injury (SCI) doesn’t end with the initial (primary) damage to the spinal cord. The accumulation of reactive oxygen species after a traumatic nerve injury causes profound secondary damage and disability. Neupron™ is a nanoparticle drug combination that delivers antioxidant enzymes directly to the site of injury and creates a protective, regenerative environment around the damaged nerves.

Image courtesy of Journal of Controlled Release; Vol 364; Hayder Jaffer, Syed Suhail Andrabi, Marianne Petro, Youzhi Kuang, Michael P. Steinmetz, Vinod Labhasetwar; Catalytic antioxidant nanoparticles mitigate secondary injury progression and promote functional recovery in spinal cord injury model; 2023. Used with permission from Elsevier

The physical impact/trauma that immediately damages the spinal cord tissue rapidly activates progressive degenerative events known as “secondary injury”.  This secondary injury expands and, with time, affects the entire spinal cord, increasing the level of disability and diminishing the prospect of regaining neurological and functional recovery.  Beyond the obvious paralysis that serve as an outward sign of the injury, SCI affects the whole body, including bladder, bowel, respiratory, cardiovascular, and sexual function — with social, psychological and economic implications.  Neuropathic pain brings additional suffering to victims of SCI.

In the United States, more than 300,000 people live with SCI, with nearly 18,000 new cases added annually. Globally, more than 20 million individuals have long-term disabilities from SCI, and nearly a million more people suffer SCI each year. Young people with SCI face a lifetime of disability and personal and societal burdens, including a 2 to 5 times higher risk of premature death than the general population. 

While the personal toll is profound, the economic toll of SCI is considerable. The annual healthcare cost for SCI patients in the US alone is approximately $60 billion. Despite the urgent need for treatments that preserve and heal the injured spinal cord, there are currently no approved treatments for SCI. Neupron is being developed as an early therapeutic intervention to protect the injured spinal cord from further degeneration and promote healing of the lesion cavity. 

At AxoNeural Therapeutics, we want to change that. Soon after the SCI, there is excessive production of reactive oxygen species (ROS) at the lesion site, which acts as the key trigger to the cascade of degenerative events, causing inflammation and overexpression of apoptotic factors, resulting in further spinal tissue death.  This self-propagating progressive degeneration eventually affects the entire spinal cord, exacerbating disability with time.

Neupron is a patented injectable formulation of nanoparticles encapsulating antioxidant enzymes.  In a preclinical model study of SCI, intravenous injection of Neupron is shown to localize at the injured site, neutralizing the toxic effect of ROS.  The regaining of redox balance at the lesion site is demonstrated to protect the injured spinal cord from progressive degeneration, promoting healing of the lesion cavity thus regaining recovery.  AxoNeuronal Therapeutics intends to develop Neupron as an early therapeutic intervention to stabilize the injured spinal cord.  This is anticipated to facilitate recovery from spinal cord injury to improve the quality of life.

Changing the dynamics in injured spinal cord: By restoring the redox balance at the lesion site, Neupron changes the dynamics in the injured spinal cord microenvironment from degenerative to regenerative, thus protecting and promoting healing.

Impact of SCI on vital organ functions: Injury to the spinal cord impacts nearly every organ in the body, and hence it is commonly referred to as “Multi-organ Disease”. Following SCI, increased systemic levels of inflammatory cytokines and reactive oxygen species, cause damage to vital organ functions.

While Neupron has its main effect at the site of spinal cord injury, its initial systemic distribution protects vital organs from damaging effect of reactive oxygen species.

Learn more about the science behind Neupron

How Neupron Works
Jaffer H, Andrabi SS, Petro M, Kuang Y, Steinmetz MP, Labhasetwar V. Catalytic antioxidant nanoparticles mitigate secondary injury progression and promote functional […]
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Animal Data
Gao Y, Vijayaraghavalu S, Stees M, Kwon BK, Labhasetwar V. Evaluating accessibility of intravenously administered nanoparticles at the lesion site in rat […]
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Vidhya Gopalakrishnan, PhD

Chief Operating Officer

Vidhya Gopalakrishnan, Ph.D., is a Director for the company. She has more than 24 years of experience in pharmaceutical research and development and operations, having led various product development programs from preclinical through Phase 3 development and new drug application (NDA) submission. She has broad experience spanning various delivery platforms and therapeutic areas including central nervous system, kidney, and ophthalmology indications. Dr. Gopalakrishnan was most recently Chief Development Officer for Retrotope, Inc., a clinical-stage company investigating new treatments for rare and orphan neurodegenerative diseases. Previously, she has served as Senior Vice President, pharmaceutical development, at Quark Pharmaceuticals, a late clinical stage company developing siRNA therapeutics. In this role, she built a CMC department and led drug development and manufacturing activities ranging from pre-IND and IND stages to NDA submissions. She also oversaw process validations in anticipation of product registration, as well as supply chain activities. Prior to Quark, she held various positions including SVP, R&D operations, at Neuraltus Pharmaceuticals, where she was responsible for the strategy and development of Neuraltus’s clinical drug candidates for neurodegenerative diseases. In addition, she has previously held other leadership positions at Jazz Pharmaceuticals, Aerogen, ALZA, and Cygnus.

Dr. Gopalakrishnan received her Ph.D. in oligoribonucleotide synthesis and structural studies from National Chemical Laboratory, Pune, India and her master’s degree in chemistry from IIT, Madras. She has held post-doctoral positions at Penn State University and Stanford University School of Medicine.

Elizabeth Sump

Senior Director

As Senior Director of Strategic Alliance and Technology Development at Cleveland Clinic, Elizabeth is responsible for building development plans for both early-stage and late-stage healthcare technologies, including start-up formation and regulatory management. She also plays a strategic role in formation and management of technology-focused consortia and public-private research partnerships. Prior to this role, she served as Senior Director of Health Policy at Cleveland Clinic, with a focus on reimbursement policy and advanced payment models. Elizabeth previously has served in several roles, including as Chief Commercialization Officer for the Armed Forces Institute of Regenerative Medicine. A native Buckeye, she received her Bachelor of Science from Ohio State University and has more than 35 years’ experience in the for-profit and non-profit business sectors with an emphasis on defense-related healthcare technologies.

Michael Steinmetz, MD

Medical Advisor

Michael P. Steinmetz, MD, serves as AxoNeural’s medical advisor. He is the William and Amanda Madar Chairman of the Department of Neurosurgery at Cleveland Clinic. He is Professor and Chairman of Neurological Surgery at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. His areas of expertise and clinical and research interests include complex spine surgery, minimally invasive surgery, spine trauma and spinal cord injury. He has published greater than 200 articles in leading medical journals, is co-author of the text, Anatomical Basis of Neurologic Disease (2009), with a 2nd Edition currently under revision, and is co-editor of Benzel’s Spine Surgery. Dr. Steinmetz is a Deputy Editor for The Spine Journal and is the Senior Chairman of the Editorial Board of Journal of Neurosurgery spine, World Neurosurgery, Operative Neurosurgery and is a reviewer for several additional journals. He has contributed more than 60 Chapters to the body of surgical spine care literature, with several more in progress. 

Dr. Steinmetz served on the Executive Committee of the Congress of Neurological surgeons including Vice President. He is a past Chairman of the Council of Neurosurgical State Societies and the CNS/American Association of Neurological Surgeons (AANS) Joint Section on Diseases of the Spine & Peripheral Nerves. He recently completed a term as Ex Officio of the AANS Executive Committee. He is a member of the AANS Annual Meeting Committee and the Chair Elect of the Scientific Program Committee. Dr. Steinmetz is a member of the AANS Practice Management Committee. He is the Vice Chairman of the Neurosurgery Quality Council and an active member of Neurosurgery PAC Board of Directors, NPA Board of Directors and Digital Users Subcommittee. He is a liaison to the Washington Committee and recently a two year term on the AANS Nominating Committee.

Dr. Steinmetz He received his degree from Texas Tech University School of Medicine, Lubbock TX, interned in General Surgery at University of New Mexico, Albuquerque, NM, and completed his residency at Cleveland Clinic Department of Neurosurgery. During residency training, Dr. Steinmetz completed two years of research fellowship in the Neuroscience Lab of Jerry Silver, PhD, at Case Western Reserve University. He was a post-graduate complex spine surgery fellow at University of Wisconsin, Madison, WI.

Vinod Labhasetwar, PhD

Founder and CSO, AxoNeural Therapeutics, Inc.

Dr. Labhasetwar is a professor and holds an endowed chair in nanomedicine at the Biomedical Engineering department of the Lerner Research Institute, Cleveland Clinic, Cleveland. With a career spanning over three decades, his laboratory has been dedicated to advancing the field of nanoparticle-based drug delivery. The research scope ranges from fundamental mechanistic studies to translational and clinical applications, all with the overarching goal of developing effective nanomedicine for diseases lacking treatment options or requiring significant improvement in clinical outcomes. For the past two decades, Dr. Labhasetwar has been at the forefront of investigating antioxidant enzyme delivery systems, notably Neupron, aimed at addressing neurological conditions and neurodegenerative diseases.

Dr. Labhasetwar has significantly contributed to the field of nanomedicine through extensive publications and is widely recognized as a top-tier, highly cited investigator. His achievements include being honored as a Young Investigator at the University of Michigan, Ann Arbor, achieving the status of a Distinguished Scientist at the University of Nebraska Medical Center, Omaha, and holding an Endowed Chair of Nanomedicine at the prestigious Cleveland Clinic.

Furthermore, his impact extends to the realm of intellectual property, with 14 US granted patents to his name. Additionally, he is an inventor on several EU granted patents and has numerous pending patent applications in both the US and EU. Notably, one of his licensed technologies is currently undergoing human trial, showcasing the translational success of his innovative work in nanomedicine.