Preclinical Data Demonstrate Ability To Regenerate An Entire Bladder With Tengion Neo-Bladder Replacement(TM)

Main Category: Urology / Nephrology
Article Date: 27 May 2008 - 11:00 PDT

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Tengion, Inc., a clinical stage biotechnology company focused on the development of neo-organs and neo-vessels, presented preclinical efficacy data for its Tengion Neo-Bladder Replacement™ at the Annual Meeting of the American Urological Association (AUA) in Orlando, Florida on May 18, 2008. The data were presented by Tim Bertram, D.V.M., Ph.D., Senior Vice President, Science and Technology of Tengion, during both a poster session and a press briefing sponsored by the AUA.

"In this well-established preclinical model, the Neo-Bladder Replacement was able to achieve functional recovery and a regenerative response that emulated the native bladder," said Dr. Bertram. "These data join the existing body of information from the preclinical studies of our first product candidate, the Tengion Neo-Bladder Augment, and underscore the promise and potential of our Autologous Organ Regeneration Platform as a foundation for our pipeline of regenerative medicine products"

The preclinical study presented at AUA was a six-month, single-arm study to evaluate the application of Tengion's technology to regenerate an entire urinary bladder. Neo-Bladder Replacements were produced from autologous bladder cells seeded onto a biodegradable scaffold and were then surgically implanted into 23 large mammals.

In this study:

- Tengion's Neo-Bladder Replacement was able to regenerate an entire urinary bladder within six months after implantation

- The regenerated bladder demonstrated near-baseline capacity and cystography by six months after implantation

- The regenerated bladder wall structure consisted of three layers: urothelium, muscle, and serosa by approximately two months after implantation

- The regenerated bladder wall showed near native pharmacological and electrophysiological functional responses by six months after implantation

Tengion is currently conducting a GLP study of its Neo-Bladder Replacement to support a planned request to the FDA in the near future to initiate human clinical trials in 2009. Additionally, Tengion is currently conducting three Phase 2 clinical trials of its Neo-Bladder Augment at 12 leading academic medical centers across the United States: one in children with neurogenic bladder due to spina bifida, one in adults with neurogenic bladder due to spinal cord injury and one in adult patients with overactive bladder (OAB) and urge incontinence.

About Tengion

Tengion, a clinical stage biotechnology company, focuses on developing, manufacturing and commercializing human neo-organs and neo-tissues using our Autologous Organ Regeneration Platform™. Tengion uses biocompatible materials and a patient's own (autologous) cells to create neo-organs or neo-tissues that are designed to catalyze the body's innate ability to regenerate. Tengion's product candidates may ultimately address the most critical problems facing organ and tissue failure patients, enabling people to lead healthier lives without donor transplants or the side effects of related therapies.

http://www.tengion.com

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