"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," said Steven Nichtberger, M.D., president and chief executive officer of Tengion.
For many bladder cancer patients who have their cancerous bladders removed, the current standard of care is the surgical creation of a urinary diversion using a segment of the patient's own bowel tissue to carry urine from the kidneys to a plastic bag on the abdominal wall. Tengion's Neo-Urinary Conduit is built from a patient's own cells obtained from a fat biopsy. The product is designed to catalyze 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. Complications most often associated with the current standard of care include bowel obstructions, bowel leakage, systemic absorption of urine via the bowel tissue, recurrent infections, stone formation, and mucus secretion in the urine.
The ongoing study, which initially will enrol 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 optimize the surgical technique and the ideal post-surgical patient care before proceeding into larger trials. The surgical procedure may be modified in subsequent patients based on the experience gained by the prior patient(s) enrolled.
The primary safety and efficacy assessment of the Neo-Urinary Conduit will be made at 12 months post-implantation. During this first year, however, patients will be seen frequently by the study investigator and/or designated clinical team: every one to two weeks after hospital discharge through week eight, and then at month 3, 6, 9 and 12. Imaging will be performed at three-month intervals for the first year to examine the neo-organ's structure, patency and identify any obstructions or other abnormalities.This frequent evaluation and the open-label nature of this study will provide significant ongoing feedback throughout the study.
According to the National Cancer Institute, bladder cancer is the sixth most common form of cancer in the United States with approximately 10,000 cases per year of bladder cancer requiring bladder removal. Following bladder removal, these patients require some form of urinary diversion and most 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.
Tengion, a clinical-stage biotechnology company, has pioneered the Organ Regeneration Platform that enables the company to create proprietary product candidates that are intended to harness the intrinsic regenerative pathways of the body to produce a range of native-like organs and tissues.
Source: Tengion, Inc.
