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

Findings Presented at American Academy of Pediatrics National Conference &

Exhibition

SAN FRANCISCO and EAST NORRITON, Pa., Oct. 29 /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.

About Tengion

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.


'/>"/>
SOURCE Tengion, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Reforming FDA: Focus on safety, let market judge efficacy
2. Chemical Stability of Disposables
3. Chemical Stability of the Brinkmann Bottletop Dispenser and the Brinkmann Bottletop Buret
4. Cell Proliferation and Viability Measurement
5. Rapid hit confirmation and early hERG liability testing using the IonWorks HT system
6. DNA Stability with Oragene
7. FluoroMax multiwavelength capability
8. Near IR capability of the FluoroLog
9. LIVE/DEAD Viability/Cytotoxicity Assay for Animal Cells Using the SpectraMax Gemini XS Fluorescence Microplate Reader (MaxLine Application Note #43)
10. The Affymetrix GeneChip Scanner 3000 New Advances in Scanner Design for Superior Performance, Reliability, and Dynamic Range
11. Promegas Multiplexed Cell Viability and Apoptosis Assays performed on the PHERAstar
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/21/2017)... ... February 21, 2017 , ... Creation Technologies, a private company ... equipment manufacturers (OEMs) , today announced it has received the ‘Highest Overall Customer ... in its category of electronics manufacturing services (EMS) providers with annual revenues over ...
(Date:2/21/2017)... , Feb. 21, 2017  Lexus, a returning partner of the ... the official and exclusive automobile partner of the men,s and women,s ... The 2017 Amgen Tour of California ... feature some of the best professional cycling teams in the world ... 14-20. The four-day Amgen Breakaway from Heart Disease TM ...
(Date:2/21/2017)... Scientists From Two Companies to ... Industry  ... STEER, creator of advanced materials platform technologies ... of plastics, pharmaceuticals, food and nutraceuticals, biomaterials and biorefining, today ... & technology company, on creating co-rotating twin screw extruder ...
(Date:2/21/2017)... Feb 21, 2017 Research and Markets has ... Analysis & Trends - Industry Forecast to 2025" report to ... ... a CAGR of around 12.8% over the next decade to reach ... analyzes the market estimates and forecasts for all the given segments ...
Breaking Biology Technology:
(Date:2/21/2017)... LONDON , February 21, 2017 ... um 70 Millionen US-Dollar wachsen. Nach einem Gespräch mit mehr ... es einige Hindernisse zu überwinden gilt, um diese Prognose ... ... unter anderem die Mobilisierung der finanziellen Mittel für die ...
(Date:2/10/2017)... DUBLIN , Feb 10, 2017 ... PharmaBiotech,s new report "Personalized Medicine - Scientific and Commercial ... ... in personalized medicine. Diagnosis is integrated with therapy for selection ... emphasis on early detection and prevention of disease in modern ...
(Date:2/8/2017)... , Feb. 7, 2017 The ... largely by the confluence of organizations, desires to ... for knowledge-based systems (password and challenge questions), biometrics ... and government systems. The market is driven by ... demarcation between consumer and enterprise uses cases, with ...
Breaking Biology News(10 mins):