Tengion permits second patient enrollment in Neo-Urinary Conduit for bladder cancer

Nov 16 2010

Tengion, Inc. (Nasdaq: TNGN), a leader in regenerative medicine, announced today that the scheduled one-month, post-operative clinical assessment of the first implanted bladder cancer patient in its ongoing clinical trial has been completed as expected and has permitted the second patient to be enrolled without delay.  The protocol for this initial clinical trial calls for each of the first few patient implantations to occur at least eight weeks after the previous patient surgery.  The surgical procedure may be modified in subsequent patients based on the experience gained by the prior patient(s) enrolled.  No modifications to the protocol have been made based on the experience with the first patient.

"We are very encouraged by the response we have seen so far in our first patient and we look forward to continuing to advance this trial and to enrolling additional patients," commented Sunita Sheth, M.D., Vice President and Chief Medical Officer at Tengion.

This trial is evaluating Tengion's Neo-Urinary Conduit in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy).  The ongoing study 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 first two patients are being treated at the University of Chicago Medical Center by the principal investigator at the site for this study, Gary D. Steinberg, M.D., Professor of Surgery and Director, Urologic Oncology. The trial is also being conducted at a second clinical site at The Johns Hopkins Hospital in Baltimore, Maryland.

Tengion expects to implant five patients by the middle of 2011 with scheduled three-month clinical assessments on all patients expected to be completed in the second half of 2011.  The Company anticipates providing an enrollment update on this trial with its next quarterly financial report.