The University of Arizona Medical Center is one of 60 trauma centers in the United States, Canada and Europe selected to conduct a clinical trial of a new investigational drug that could help people with acute spinal cord injuries (ASCI) experience less spinal cord damage and have improved function.
Researchers are evaluating the safety and efficacy of an investigative new drug called SUN13837 to determine whether it can protect and regenerate the spinal nerves in ASCI patients. To be considered for the study, a participant must have suffered a spinal cord injury within 12 hours prior to receiving the first dose of the medication and be available for daily dosing for 28 consecutive days.
UAMC is the only Level I Trauma Center in the Southwest involved in the two-year study. UA Department of Surgery surgeons Randall Friese, MD, professor, Division of Trauma, Critical Care, Burn and Emergency Surgery, and Rein Anton, MD, PhD, assistant professor, Division of Neurosurgery, are leading the study.
Acute spinal cord injury occurs in 13,000 to 15,000 individuals in the United States each year; well over half of the cases experience quadriplegia. The estimated lifetime cost of acute spinal cord injury for a 25-year-old patient is in the millions of dollars.
At present, no drug has been approved by the U.S. Food and Drug Administration or Health Canada to treat the paralysis and sensory loss that occurs after ASCI. The study is sponsored by Asubio Pharmaceuticals, Inc., a Daiichi Sankyo Group Company.
In this randomized trial, patients will be assigned to receive either a placebo or SUN13837 within 12 hours of injury and then daily for 28 days. Researchers will determine if subjects receiving SUN13837 are more likely to respond to the treatment (and to what extent) compared to those in the placebo group. The drug level in the blood stream will be compared to the response to determine the relationship between dose, effect (efficacy or clinical symptoms) and safety.
Beta fibroblastic growth factors (bFGF) keep neurons alive and healthy and promote regrowth. SUN13837 mimics bFGF properties. Currently, growth-factor therapies have delivery issues because they are large proteins and difficult to inject. This new compound is a smaller molecule with good blood-brain barrier penetration that can be given intravenously.
The study is designed as a collaboration among trauma centers and rehabilitation and spine centers. Typically, these centers have not participated together in clinical programs and it is hoped this study will lead to further cooperation in future clinical programs. UAMC patients in the study will be followed at HealthSouth Rehabilitation Institute of Tucson.
“We are pleased to have been chosen participate in this important multi-center trial. Opportunities like these enable the physicians and health-care providers at UAMC to bring new and cutting-edge therapies to our community,” said Dr. Friese.
For more information on this ASCI research study in patients, please call UA study coordinator Laurel Rokowski, RN, 520-626-2876 or visit our website at www.surgery.arizona.edu.