Tengion initiates third Phase II overactive bladder trial

This new Phase II clinical trial in adults with non-neurogenic over-active bladder (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 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.

Steven Nichtberger, president and CEO of Tengion, said: “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.”