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Tengion Launches Second Phase 2 Clinical Trial of Regenerated Human Organ
Date:9/17/2007

Trial Aims to Study Safety and Efficacy of Tengion's Neo-Bladder Construct

in Spinal Cord Injury Patients

EAST NORRITON, Pa., Sept. 17 /PRNewswire/ -- Tengion, Inc., a leader in regenerative medicine, announced today it has initiated a Phase 2 multi-center clinical trial of its neo-bladder construct, derived from a patient's own cells. The U.S.-based study is being conducted in 10 adult patients with neurogenic bladder due to spinal cord injuries. Neurogenic bladder is a condition that can occur due to spinal cord injury and may lead to kidney failure and incontinence, even when patients receive optimal medical treatment.

This Phase 2 trial initiation follows the successful completion of enrollment in the company's first (Phase 2) clinical trial of the autologous neo-bladder construct in pediatric patients with neurogenic bladder due to spina bifida. The commencement of Tengion's spina bifida Phase 2 clinical trial was announced in the first quarter of 2007.

"Tengion's novel regenerative medicine platform aims to address the significant limitations of current treatment options for patients with organ and tissue failure or loss," said Steven Nichtberger, M.D., President and CEO of Tengion. "Our neo-bladder constructs, which harness the body's natural ability to regenerate organs and tissues using a patient's own cells, hold the promise to meet critically important unmet medical needs. We look forward to announcing results from both of these Phase 2 clinical studies."

Similar to the Phase 2 study in pediatric patients, the new Phase 2 study in adult patients with spinal cord injuries is evaluating the safety and effectiveness of the neo-bladder construct at one year after implantation. The neo-bladder construct design is based on nearly two decades of research from Children's Hospital Boston (a teaching affiliate of Harvard Medical School), MIT, The Wake Forest Institute for Regenerative Medicine and Tengion. Previ
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SOURCE Tengion, Inc.
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