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Tengion Announces IND Filing for Neo-Kidney Augment Expected During First Half of 2013
Date:4/17/2012

ease in functional kidney mass could thereby delay or prevent the need for dialysis or kidney transplant in patients with end stage renal disease (ESRD). According to the United States Renal Data System, more than $27 billion in Medicare costs each year are attributable to patients with ESRD and ESRD is associated with an approximate 20% mortality rate per year, with the average life expectancy of a patient initiating dialysis of approximately four years. Tengion scientists have published and presented positive data on the effect of the Company's Neo-Kidney Augment in four different preclinical models of CKD. Two of these preclinical models have been conducted for a sufficiently long period of time to demonstrate durability and an impact on survival. Tengion anticipates submitting an IND filing for the Neo-Kidney Augment to FDA during the first half of 2013. 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.

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-like urinary 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 candidate currently in development that aims to avoid the use of bowel tissue. The Neo-Urinary Conduit is being evaluated in an ongoing
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SOURCE Tengion, Inc.
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Related medicine technology :

1. Tengion Launches Second Phase 2 Clinical Trial of Regenerated Human Organ
2. Tengion Launches Third Phase 2 Clinical Trial of Regenerated Human Bladder
3. Preclinical Data Demonstrate Ability to Regenerate an Entire Bladder With Tengion Neo-Bladder Replacement(TM)
4. Tengion Scientists Publish Key Preclinical Findings Demonstrating the Benefits of Organ Regeneration Vs. Repair
5. Tengion Appoints Sunita B. Sheth, M.D., Chief Medical Officer
6. Tengion Presents New Data Demonstrating Functional Regeneration in a Diabetic Chronic Kidney Failure Model at the International Society for Cellular Therapy
7. Tengion Announces First Implantation of Neo-Urinary Conduit™ in Initial Clinical Trial in Patients with Bladder Cancer
8. Tengion Reviews Pipeline Progress at First Analyst and Investor Meeting; Strategic & Clinical Updates Provided for Regenerative Medicine Programs
9. Tengion Provides Business Update and Reports Third Quarter 2010 Financial Results
10. Tengion Advances Clinical Trial for Neo-Urinary Conduit™ in Bladder Cancer Patients
11. Tengion Presents New Data in Nine Posters and Two Oral Presentations at TERMIS North America Annual Meeting
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