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

toward symptomatic and quality of life improvement.

"Many patients do not achieve optimal results from the currently available treatments for OAB and urge incontinence," said Dr. Patrick Shenot, Assistant Professor in the Department of Urology at Jefferson Medical College of Thomas Jefferson University. "While the Neo-Bladder will not be the appropriate course of treatment for all OAB patients with urge incontinence, this procedure has the potential to dramatically improve quality of life in those patients for whom other treatment options have failed."

This Phase 2 clinical trial in adults with OAB and urge incontinence is the third Phase 2 trial initiated since January 2007 to assess the safety and efficacy of the Tengion Neo-Bladder Augment(TM) in a range of patients suffering from various forms of bladder failure and impairment. In September 2007 Tengion announced the successful completion of enrollment of a Phase 2 clinical trial of the Neo-Bladder Augment for neurogenic bladder due to spina bifida and the initiation of a Phase 2 clinical trial of the Neo-Bladder Augment for neurogenic bladder due to spinal cord injury.

According to The World Journal of Urology, over-active bladder (OAB) is a condition that affects approximately 33 million people in the United States. A subset of patients with OAB has associated urge incontinence. This condition affects approximately 12 million patients. A study conducted by the National Overactive Bladder Evaluation (NOBLE) Program in 2002 showed that OAB, with or without urge incontinence, was associated with clinically and significantly lower quality-of-life, depression and poorer quality of sleep. Each year there are thousands of patients in the U.S. with severe urge incontinence who have failed all existing therapies, resulting in a loss of their ability to work and / or to engage in normal personal activities.

"Tengion's novel regenerative medicine platform is focused on developing products to
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SOURCE Tengion, Inc.
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