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Preclinical Efficacy Data Demonstrate Ability of Tengion's Neo-Bladder Augment to Restore Bladder Function
Date:10/29/2007

d and autologous urothelial and smooth muscle cells (Neo-Bladder Group, n=32) was compared to re-implanted native bladder (Re-implant Group, n=32) and to biodegradable scaffold alone (Scaffold Group, n=8) at 1, 3, 6 and 9 months post-implantation.

The study findings show that within 14 days, all 72 subjects were continent and within 1 month their acute phase responses, hematological and urinalysis parameters had returned to baseline. However, only the group receiving the Tengion Neo-Bladder Augment achieved functional recovery (i.e., urodynamics) and a regenerative tissue response that emulated the native bladder's structure, function and biofeedback. This Neo-Bladder Group regained baseline bladder capacity by 4 months and compliance by 6 months. These findings were sustained throughout the study. Further, activity and in- life findings for the Neo-Bladder Group were consistent with common post- operative findings of a major abdominal surgery -- there was no evidence of bladder tearing or rupture, stone formation, abdominal adhesions, abscess formation, or post-operative morbidity/mortality.

In contrast, over time the Re-implant Group became unstable, with urodynamic parameters significantly lower than baseline by 9 months (60-75% decrease from baseline). Further, the Re-implant and Scaffold Groups showed urodynamically decreased compliance at 9 months that correlated histologically with limited healing and incomplete bladder wall regeneration. Finally, treatment-related morbidity was only observed in the Re-implant and Scaffold Groups.

According to the data, the Tengion Neo-Bladder Augments were safe and able to restore urodynamic, continence, and voiding functions by 6 months and retained these functions to study termination. It is important to note that bladder wall regeneration was obtained only in the animals implanted with the Tengion Neo-Bladder Augment. These data are outlined on a poster presented today at the AAP National Conference and
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SOURCE Tengion, Inc.
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