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Tengion Provides Update on Neo-Urinary Conduit Clinical Trial
Date:6/13/2011

EAST NORRITON, Pa., June 13, 2011 /PRNewswire/ -- Tengion, Inc. (Nasdaq: TNGN) today provided an update on the clinical trial of the Company's lead clinical product candidate, the Neo-Urinary Conduit™, for use in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). Tengion is continuing to work with investigators to optimize the surgical approach as part of its ongoing clinical trial of the Neo-Urinary Conduit in patients with bladder cancer and is working closely with clinical investigators, the Data Safety Monitoring Board (DSMB) and the U.S. Food and Drug Administration (FDA) to advance the study.

"As planned, we have reviewed clinical data from our ongoing trial with the investigators, the DSMB, and the FDA," said Sunita Sheth, M.D., Chief Medical Officer and Vice President Clinical and Regulatory Affairs of Tengion. "Based on these discussions, a plan has been developed to collect additional clinical data while modifying the surgical approach for future implants.  We expect to submit these data and changes to the FDA in the third quarter, prior to enrolling additional patients in the trial."  

The study is designed to provide data on the safety profile and preliminary efficacy for the Neo-Urinary Conduit as an alternative to the current standard treatment requiring the use of a patient's own bowel tissue, which can cause significant complications, as well as to provide investigators with data to optimize the surgical technique and post-surgical patient care during the trial. To date, three patients have been enrolled and implanted in the clinical trial at both the University of Chicago Medical Center and at The Johns Hopkins Hospital in Baltimore, Maryland.

About Bladder Cancer

The National Cancer Institute estimates that more than 70,000 new cases of bladder cancer are diagnose
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SOURCE Tengion, Inc.
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5. Tengion Reviews Pipeline Progress at First Analyst and Investor Meeting; Strategic & Clinical Updates Provided for Regenerative Medicine Programs
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