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Tengion Launches Second Phase 2 Clinical Trial of Regenerated Human Organ
Date:9/17/2007

ous academic clinical research and results of use of the neo-bladder at Children's Hospital Boston were described in an article published in The Lancet on April 15, 2006.

The neo-bladder constructs for patients in both Phase 2 clinical trials are being developed at Tengion's state-of-the-art manufacturing facility using cells taken from a small biopsy of each patient's bladder. Each neo-bladder construct consists of a biodegradable scaffold seeded with cells cultured by Tengion scientists from the patient's own (i.e., autologous) healthy cells. A surgeon implants the neo-bladder construct in the patient's body, where it is designed to harness the body's inherent regenerative capabilities resulting in a regenerated bladder with improved functionality. The primary efficacy endpoint of the trial is urodynamic function of the neo-bladder at one year post-implantation. Data on the safety profile of the product will continue to be collected after the one-year endpoint measurement date. The trial is expected to complete enrollment over the next few months.

If the implanted neo-bladder constructs prove safe and effective, they have the potential to reduce the risks and complications associated with present means of treating failing bladders in adults with spinal cord injuries. The most common surgical procedure currently used to treat patients with failing bladders is known as enterocystoplasty, a procedure that was developed more than 100 years ago that uses the patient's own bowel tissue to augment the failing bladder. This procedure is associated with substantial and well-described side effects and risks.

"Bladder failure patients have not seen new treatment options in decades, and Tengion's technology has the potential to be a compelling advance," said Roger R. Dmochowski, M.D., professor with Vanderbilt University's Department of Urology. "We have been encouraged by results to date and look forward to the continued evaluation of the neo-bladder constr
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SOURCE Tengion, Inc.
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