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Significant Milestone for Tengion Clinical Program Currently Enrolling Bladder Cancer Patients

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Tengion, Inc., a leader in regenerative medicine, announced that surgeons at the University of Chicago have implanted its Neo-Urinary Conduit(TM) 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. Steven Nichtberger, M.D., president and chief executive officer of Tengion said, 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.

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.

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