Tengion has reported that surgeons at the University of Chicago have implanted its Neo-Urinary Conduit in the first patient as part of the ongoing clinical trial evaluating the company's product candidate in bladder cancer patients requiring a urinary diversion following bladder removal.
Tengion’s Neo-Urinary Conduit is built from a patient’s own cells obtained from a fat biopsy and is designed to catalyse regeneration of native-like bladder tissue, eliminating the need to use bowel tissue as a replacement for the cancerous bladder.
The Neo-Urinary Conduit is designed to avoid many of the complications associated with the use of bowel tissue.
Tengion president and CEO Steven Nichtberger said that this implantation marks a significant milestone for bladder cancer patients and their physicians who are eager for a treatment alternative to the current standard of care.
The ongoing study, which initially will enroll up to five patients with bladder cancer following bladder removal, is designed to provide data on the safety profile for the Neo-Urinary Conduit as well as to optimise the surgical technique and the ideal post-surgical patient care before proceeding into larger trials.
The primary safety and efficacy assessment of the Neo-Urinary Conduit will be made at 12 months post-implantation.