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Tengion Launches Third Phase 2 Clinical Trial of Regenerated Human Bladder
Date:1/3/2008

address significant limitations of current treatment options for patients with organ and tissue failure or loss," said Steven Nichtberger, M.D., President and CEO of Tengion. "Our Neo-Bladders, which use a patient's own cells, catalyze the body's ability to regenerate organs and tissues and hold the promise to meet critically important unmet medical needs and improve bladder functionality. We look forward to announcing results from our Phase 2 clinical trials over the next year."

Phase 2 Study Design

This new Phase 2 clinical trial in adults with non-neurogenic OAB and urge predominant incontinence is an open-label, prospective, single-study group trial. Patients will undergo a small bladder biopsy to collect autologous urinary bladder smooth muscle and urothelial cells. At Tengion's state-of-the-art manufacturing facility, each Neo-Bladder Augment will be constructed using the patient's healthy cells from the biopsy. After approximately four to eight weeks, expanded cells will be seeded on a biodegradable scaffold to produce the Neo-Bladder Augment. Approximately one week later, a surgeon will surgically implant the Neo-Bladder Augment back into the patient's native bladder during an augmentation cystoplasty procedure.

In addition to overall safety, efficacy will be assessed through a change from baseline in mean number of micturitions, or urinations, per day as assessed by a patient diary at 12 months, plus a 48-month long-term evaluation phase. The trial is expected to complete enrollment in 2008.

About the Tengion Neo-Bladder Augment(TM)

The autologous Neo-Bladder Augment construct design is based on nearly two decades of research from Children's Hospital Boston (a teaching affiliate of Harvard Medical School), MIT, the Wake Forest Institute for Regenerative Medicine and Tengion. Previous academic clinical research and results of use of the Neo-Bladder at Children's Hospital Boston were described in an article published in The
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SOURCE Tengion, Inc.
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