TNGN has added The Johns Hopkins Hospital in Baltimore, Maryland as a 2nd clinical trial site for its Phase I clinical trial of its lead product candidate, the Tengion Neo-Urinary Conduit™ in bladder cancer patients requiring bladder removal. The initiation of the Phase I Neo-Urinary Conduit clinical trial at the University of Chicago was announced earlier this year.
- The study will initially enroll up to 5 patients with bladder cancer following bladder removal (cystectomy),
- It is designed to establish the safety profile for the product as well as to optimize the surgical technique and the ideal post-surgical patient care that is intended to provide superior clinical outcomes,
- The Neo-Urinary Conduit is an implant designed to catalyze regeneration of native-like urinary tissue in patients who require a urinary diversion following cystectomy,
- The Neo-Urinary Conduit is produced using the patient’s own smooth muscle cells from a routine fat biopsy and not cells from the diseased bladder, eliminating the risk of reintroducing cancerous cells from the bladder into the patient.
According to the National Cancer Institute, bladder cancer is the 6th most common form of cancer in the US with approximately 10,000 cases per year of bladder cancer requiring bladder removal.
- Following bladder removal, patients require some form of urinary diversion. Most patients are currently treated by using a segment of bowel tissue to construct a conduit for urine to exit from the body into an ostomy bag,
- In its simplest form, the reconstruction involves creating a tubular structure out of bowel tissue and then connecting it to the ureters at one end and the skin at the other.