Asubio broadens inclusion criteria for spinal cord injury trial
Asubio Pharmaceuticals has expanded enrollment for its ASCENT-ASCI (Asubio Spinal Cord Early Neuro-recovery Treatment for Acute Spinal Cord Injury) trial to include AIS A, B and C injury to the cervical spine. ASCENT-ASCI is a phase II clinical trial evaluating SUN13837, an investigational medication being developed to improve neurological function in patients with newly diagnosed acute spinal cord injury.
The company is currently working with 45 acute trauma centers throughout the U.S. and Canada and plans to increase to 55 centers. Trauma centers must first sign up to participate in the trial and then brief attending trauma physicians and nurses on how to rapidly identify eligible spinal cord injury patients when they first arrive at their facility. There are also 13 standalone rehabilitation centers participating.
"The recent adoption of a more inclusive Asubio trial protocol will meet the needs of a broader number of spinal cord injuries and enable a more sensitive and accurate determination of therapeutic benefit across a wider range of functional disability," said John Steeves, Ph.D., professor and founding director of ICORD (International Collaboration On Repair Discoveries).
"It takes a small community to pull off an acute spinal cord injury study, but with a bit of planning, it can be done," explained Laura Wollenweber, a clinical research coordinator at the Medical College of Wisconsin in Milwaukee, who spoke of her experience enrolling patients in the study. "We are hopeful that the broadened enrollment criteria will bring new hope for a wider range of patients."