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Tengion Announces Significant Advances in Neo-Urinary Conduit™ and Neo-Kidney Augment™ Programs
Date:3/26/2012

ll complete implantation of up to 10 patients by the end of 2012.

Neo-Kidney Augment Preclinical Program Update
Tengion submitted a pre-IND filing to the FDA for its lead preclinical program, the Neo-Kidney Augment, one quarter ahead of schedule. The Neo-Kidney Augment is intended to prevent or delay the need for dialysis or kidney transplant by catalyzing the regeneration of functional kidney tissue in patients with advanced chronic kidney disease (CKD). Following the early submission of the pre-IND, Tengion's Board of Directors has authorized the Company to aggressively pursue the development of its Neo-Kidney Augment program and will retain the full team of employees involved in the Neo-Kidney Augment program.

Tengion has scheduled a meeting with the FDA to discuss the Company's proposed GLP animal study program to support an IND filing. Tengion is also exploring moving forward using the Advanced Therapy Medicinal Products (ATMP) pathway, an established regulatory route in Europe for advanced cell-based therapies. The Company expects to provide an update on its expectations for the clinical trial program in its first quarter 2012 financial results announcement in May.

About the Neo-Urinary Conduit
The Neo-Urinary Conduit is a combination of a patient's own cells and bioabsorbable scaffold that is intended to catalyze regeneration of a native bladder tissue conduit, passively transporting urine from the ureters through a stoma, or hole in the abdomen, into a standard ostomy bag. Standard of care for patients requiring a non-continent urinary diversion uses bowel tissue to construct a conduit for urine to exit from the body. There are over 20,000 urinary diversions performed annually in the United States and Europe. These patients are at risk for complications associated with the use of bowel tissue, as well as for those associated with the surgery to harvest the bowel tissue. The Neo-Urinary Conduit is the only product c
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SOURCE Tengion, Inc.
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