Preclinical Efficacy Data Demonstrate Ability of Tengion's Neo-Bladder Augment to Restore Bladder Function
SAN FRANCISCO and EAST NORRITON, Pa., October 29, 2007 /PRNewswire/ -- Tengion, Inc., a leader in regenerative medicine, announced today that findings from a preclinical study being presented today at the American Academy of Pediatrics (AAP) National Conference and Exhibition demonstrate the ability of the Tengion Neo-Bladder Augment(TM) to restore bladder function in a well- established preclinical model of a bladder augmentation cystoplasty. These data were among the key findings that served as the basis for the company's 2006 Investigational New Drug (IND) submission with the U.S. Food and Drug Administration (FDA) for its autologous Neo-Bladder.
"We believe these data demonstrate that the Tengion Neo-Bladder Augment is safe, effective and enables the body to truly regenerate new cells and tissues. In this well-established pre-clinical model, only the Neo-Bladder Augment group was able to achieve functional recovery and a regenerative response that emulated the native bladder," said Tim Bertram, D.V.M., Ph.D., Senior Vice President, Science and Technology of Tengion. "These Tengion data join previous academic research of the autologous Neo-Bladder construct in pediatric patients -- published in The Lancet in April 2006 -- to create a compelling foundation for the promise and potential of Tengion's pipeline of regenerative medicine products. Tengion currently has two Phase 2 clinical trials ongoing evaluating the Neo-Bladder Augment: one in pediatric patients with neurogenic bladder due to spina bifida, and the other in adult patients with neurogenic bladder due to spinal cord injuries."
The purpose of the preclinical study described at AAP was to examine the structural and functional aspects of bladder regeneration in a well- established preclinical model. To do so, Tengion's Neo-Bladder Augment composed of a biodegradable scaffold 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 Exhibition in San Francisco, California.
About the Tengion Neo-Bladder Augment(TM)
Tengion's most advanced regenerative medicine program is the autologous Tengion Neo-Bladder Augment. There are currently two Phase 2 clinical trials ongoing evaluating the Neo-Bladder Augment: one in pediatric patients with neurogenic bladder due to spina bifida, and the other in adult patients with neurogenic bladder due to spinal cord injuries. The Neo-Bladder Augments for both Phase 2 clinical trials are being developed at Tengion's state-of-the-art manufacturing facility using cells taken from a small biopsy of each patient's bladder. Each Neo-Bladder Augment consists of a biodegradable scaffold seeded with cells cultured by Tengion scientists from the patient's own (i.e., autologous) healthy cells. A surgeon implants the Neo-Bladder Augment in the patient's body, where it is designed to harness the body's inherent regenerative capabilities resulting in a regenerated bladder with improved functionality.
Tengion Inc., a clinical stage biotechnology company, is a leader in developing autologous neo-organs and tissues, such as bladders, that are derived from the patient's own (autologous) cells. Tengion's proprietary approach to regenerative medicine has the potential to enable people with organ and tissue failure to lead healthier lives without donor transplants or the side effects of current therapies. Headquartered in East Norriton, PA, Tengion also has research and pilot manufacturing facilities located in Winston-Salem, NC. For more information, visit Tengion online at: http://www.tengion.com.
CONTACT: Gary Sender, Chief Financial Officer of Tengion Inc.,+1-267-960-4802, firstname.lastname@example.org
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Posted: October 2007