First implantation of Neo-Urinary Conduit in bladder cancer patient performed at University of Chicago

Oct 25 2010

Tengion, Inc. (Nasdaq: TNGN), a leader in regenerative medicine, announced today 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 lead product candidate in bladder cancer patients requiring a urinary diversion following bladder removal. The patient is being treated at the University of Chicago Medical Center by the study's principal investigator, Gary D. Steinberg, M.D., professor of surgery and director, urologic oncology.  The trial is also being conducted at The Johns Hopkins Hospital in Baltimore, Maryland.

"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 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 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.

Further details on the Neo-Urinary Conduit development program and on the Company's product development portfolio and upcoming milestones will be presented at its Analyst and Investor Meeting on Wednesday, October 27, 2010 from 1:00 to 3:00 pm ET.