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Tengion Announces Significant Advances in Neo-Urinary Conduit™ and Neo-Kidney Augment™ Programs
Date:3/26/2012

oval (cystectomy). The trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit in up to 10 patients, as well as to translate the surgical procedure successfully used in preclinical animal models into clinical trials with human patients. The ongoing initial trial is being conducted at the University of Chicago Medical Center and at The Johns Hopkins Hospital in Baltimore, Maryland.

The goal set by the clinical investigators in this trial has been to optimize the surgical procedure and post-surgical care by incorporating the outcomes observed in each patient into the surgical approach for subsequent patients, as necessary. Data from the first three patients have allowed clinical investigators to make surgical modifications for the trial moving forward in an effort to address conduit patency and vascular supply. Complications that arose in the first three patients were resolved successfully and, following new surgeries to construct a urinary diversion using bowel tissue, all three patients have recovered well.

Upon implanting the fourth patient in the ongoing trial, Tengion and its clinical investigators believe they have translated the surgical technique, including the procedure to provide greater blood supply to the Neo-Urinary Conduit supporting regeneration of urinary tissue; the ureteral attachment to the Neo-Urinary Conduit using an established surgical procedure used in the current standard of care; and the procedure for the stoma incision and passage of the Neo-Urinary Conduit with its blood supply through the abdominal wall. The Company is also collaborating with post-operative care staff at the two trial sites to optimize stoma management for rapid patient recovery.

The Company plans to discuss with the Data Safety Monitoring Board a reduction in the timelines between future patient implants, which is currently 12 weeks. If granted and assuming appropriate safety data, the Company anticipates that it wi
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SOURCE Tengion, Inc.
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5. Tengion Appoints Diane Jorkasky, M.D., to its Board of Directors
6. Tengion Provides Update on Neo-Urinary Conduit Clinical Trial
7. Tengion Announces FDA Orphan-Drug Designation for Neo-Urinary Conduit
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