Tengion Launches Third Phase 2 Clinical Trial of Regenerated Hum...( Enrolling Patients with Urge Incon...),Health

Enrolling Patients with Urge Incontinence Who Have Failed Alternative

Therapies

EAST NORRITON, Pa., Jan. 3 /PRNewswire/ -- Tengion, Inc., a clinical stage regenerative medicine company focused on the development of neo-organs and neo-vessels, announced today it is initiating its third Phase 2 multi-center clinical trial of its Neo-Bladder Augment derived from a patient's own (autologous) cells. The U.S.-based study is being conducted at five hospitals in 10 adult patients with non-neurogenic over-active bladder (OAB) who are intolerant or not adequately responsive to medical therapy.

"OAB has a negative effect on the social and personal lives of those affected," stated Dr. Tim Boone, Chair of Urology at The Methodist Hospital in Houston and a member of the Scott Department of Urology at Baylor College of Medicine. "Men and women with inadequately treated OAB frequently experience unpredictable urgency that can lead to episodes of incontinence. Many patients with severe urge incontinence lose their ability to work or engage in normal social activities because they simply can't leave their homes without the fear of embarrassment. The major goals in bladder management of patients with OAB are to increase the capacity of the bladder, reduce the frequency of urination, and where relevant, reduce incontinence episodes."

A variety of pharmacotherapy options have been tried in the treatment of OAB, with varying degrees of success and tolerability. In the absence of either symptom improvement or ability to tolerate pharmacotherapy, more aggressive measures may be utilized, including the investigational injection of botulism toxin (e.g., Botox, Allergan), neurostimulation (e.g., InterStim, Medtronic) or surgical intervention. Surgery in this population is generally reserved for when all other therapeutic interventions have failed. The goal of surgery is to increase the functional capacity of the bladder with a view
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