A new clinical trial at UTHealth Houston is testing a gene therapy vector aimed at treating neurogenic bladder in individuals with spinal cord injuries. The trial, conducted at TIRR Memorial Hermann, uses a modified herpes virus to deliver the treatment.
Neurogenic bladder often follows spinal cord injuries, causing discoordination in normal bladder function and resulting in symptoms such as overactive bladder, frequency, urgency, and incontinence. These issues can lead to urinary tract infections and potentially permanent kidney damage.
The therapy employs a nonmultiplying gene therapy vector derived from the herpes virus. This vector carries a gene encoding the active component of botulinum toxin to block sensory nerve signals that trigger involuntary bladder contractions. Developed by biotechnology company EG 427, this therapy is known as EG110A.
Argyrios Stampas, MD, MS, lead investigator for the trial's Houston site and associate professor at McGovern Medical School at UTHealth Houston, explained: “They have modified the herpes virus... Once the vector is in place, it will manufacture its medication. It will block the sensory signals in the spinal cord that cause reflexive bladder contractions.”
Current treatments using BOTOX require numerous injections into the detrusor muscle every six months. Preclinical studies indicate that EG110A could remain effective for several years. Stampas emphasized the potential impact on quality of life: “When people living with spinal cord injury are surveyed, bowel and bladder issues are their top priority.”
The Phase Ib/IIa clinical trial spans 52 weeks and involves participants aged 18 to 75 who are at least one year post-spinal cord injury. An overnight hospital stay is required following injections due to its first-in-human nature. The U.S. Food and Drug Administration has cleared the drug for investigational use.
In addition to Houston, study sites include Rancho Los Amigos National Rehabilitation Center in Los Angeles; University of Michigan Rogel Cancer Center in Ann Arbor; and Sidney Kimmel Medical College in Philadelphia.
