Shepherd Center Treats Two Patients with Chronic Spinal Cord Injury with Potential Restorative Drug in RESET Clinical Trial
The Phase 1 study will evaluate the safety of the drug.
Shepherd Center recently treated two patients with chronic spinal cord injury in a Phase 1 clinical trial of Fusion Protein AXER-204. Shepherd is the first study site in the United States to have dosed two patients with the investigational drug, which – unlike most similar clinical trials – is focused on patients living with spinal cord injury, rather than those who are newly injured.
Shepherd Center is one of five U.S. facilities participating in the clinical trial sponsored by ReNetX Bio, Inc., a biotechnology company in New Haven, Connecticut. The goal of this trial is to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of AXER-204. Ultimately, researchers hope the drug will improve motor function by promoting neural plasticity and the regrowth of neural networks in individuals with chronic spinal cord injury.
While a single dose of AXER-204 is not expected to promote neurological recovery in humans, this Phase I clinical trial will confirm its safety and tolerability. With successful completion of the first study, the next study will evaluate the potential effects of repeated doses of AXER-204 in comparison to a placebo. AXER-204 is delivered via lumbar puncture injection into the spinal cord.
Clinical sites are still recruiting for the RESET trial.
Click here to learn more about participating in the RESET trial at Shepherd Center.
To meet the clinical trial’s eligibility criteria, patients must meet the following criteria:
- 18 – 65 years old
- Traumatic SCI that occurred more than one year ago
- Cervical SCI with weakness in the arms and/or hands
- In excellent overall health
- If any of the following apply to you, you are not eligible to participate:
- History of a stroke, brain injury or any other chronic medical condition
- Implanted baclofen or pain pump
- Require any assistance to breathe (i.e., mechanical ventilation)
“More than 17,000 people sustain a spinal cord injury each year, yet there are no FDA-approved therapeutics that could potentially restore some function in the 300,000 individuals living with a chronic spinal cord injury,” said Donald P. Leslie, M.D., medical director emeritus of Shepherd Center and the principal investigator for Shepherd Center for this clinical trial. “While we’re still in the very early phases of evaluating the safety and tolerability of AXER-204, our hope is that it will someday prove to be a viable option in restoring function in these patients.”
Working with Dr. Leslie on the clinical trial is a specialized team of clinicians in the Shepherd Spine and Pain Institute, led by Erik Shaw, D.O., and the Shepherd Center intensive care unit and Shepherd Center Pharmacy.
After spinal cord injury, the recovery of function requires the regeneration and rewiring of neurons. But in central nervous system tissue, extracellular inhibitors called Nogo-A, MAG and OMgp limit regrowth. This ongoing research involves a decoy receptor called the Nogo Trap, which binds the growth inhibitors, allowing the body to grow nerve fibers naturally and directly targeting restoration across all facets of growth. The Nogo Trap was initially developed by Stephen Strittmatter, M.D., Ph.D., at Yale University and is being commercialized by ReNetX Bio..
To learn more, please visit: shepherd.org/resources-healthcare-professionals/research/reset-trial
Shepherd Center provides world-class clinical care, research, and family support for people experiencing the most complex conditions, including spinal cord and brain injuries, multi-trauma, multiple amputations, stroke, multiple sclerosis, and pain. Ranked by U.S. News as one of the nation’s top 10 hospitals for rehabilitation and the best in the Southeast, Shepherd Center treats more than 850 inpatients and 7,600 outpatients annually with unmatched expertise and unwavering compassion to help them begin again.