For immediate release
Contact: Gary Sender
Chief Financial Officer
Tengion, Inc.
gary.sender@tengion.com
EAST NORRITON, PA, April 28, 2009 — Today, 12-month data from Tengion's Phase 2 clinical trial of the Tengion Neo-Bladder Augment™ in pediatric patients with neurogenic bladder due to spina bifida were presented during the American Urological Association (AUA) 2009 Annual Conference’s Late Breaking Science Forum. These data, part of a poster presentation, were presented by an investigator in the Phase 2 clinical trial, David B. Joseph, M.D., Professor of Surgery, University of Alabama and Chief of Pediatric Urology, Children’s Hospital, Birmingham, Alabama.
These data support our belief that the Tengion Neo-Bladder Augment can be utilized for successful augmentation in patients with neurogenic bladder, and also helped us identify which patients are most likely to benefit from the Tengion Neo-Bladder Augment. Importantly, the study replicated the landmark scientific research published in The Lancet in April 2006 that outlined the initial human experience and academic findings of Dr. Anthony Atala, Tengion’s scientific co-founder.
Tengion is currently working to further analyze these 12-month data to better understand the improvements seen in urodynamic compliance and continence and the role that bladder "cycling" played in patients' responses. Along with our Phase 2 and prospective Phase 3 clinical investigators, Tengion is also reviewing the safety data from the trial to further examine two safety events - both of which occurred after the initial 12-month endpoint and have been fully resolved - and is evaluating how to optimize the current trial protocol and surgical procedures to minimize the risk of these events in the future. These two safety events were reviewed and discussed during the presentation at the AUA meeting. The results of these analyses, along with the output of in-progress regulatory discussions with FDA and conversations with key clinicians, will help Tengion finalize the design of its Phase 3 trial of the Neo-Bladder Augment.
In addition to these 12 month Phase 2 data, Tengion and its clinical investigators also presented separate posters and presentations at the AUA 2009 Annual Conference that demonstrated the Neo-Bladder Augment's bio-responsive ability to grow with the patient, adapting to individual patient needs in both size and function, and confirmed the important role of bladder cycling in promoting tissue regeneration and optimal healing following Neo-Bladder Augment implantation.
About Tengion
Tengion is a clinical-stage organ regeneration company with products in urologic, vascular and renal regeneration based on its proprietary 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 is a fully-integrated organization, with scalable U.S. and European manufacturing and distribution capabilities, experienced research, development, clinical and commercial teams, and significant intellectual property. 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.