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Tengion Provides Business Update and Reports Third Quarter 2012 Financial Results
Date:11/13/2012

Urinary Conduit died due to afflictions unrelated to the product candidate or the surgical procedure. The fourth patient enrolled in the trial died of metastatic bladder cancer and the sixth patient passed away from a cardiopulmonary arrest following a myocardial infarction. Until their deaths, both patients' Neo-Urinary Conduits functioned well and they maintained normal renal function.

Following a positive meeting with the Data Safety Monitoring Board (DSMB) and the U.S. Food and Drug Administration (FDA), the Company is proceeding with concurrent enrollment of the remaining four patients in the Phase 1 clinical trial. Tengion is actively recruiting and remains focused on enrolling the remaining four patients in the trial by the end of 2012, however the timing of enrolling the seventh patient may result in completing enrollment of this trial in the first quarter of 2013.

There are four clinical trial sites actively recruiting patients for this clinical trial. These include the two original centers, the University of Chicago Medical Center and The Johns Hopkins Hospital in Baltimore, MD, as well as Baylor College of Medicine in Houston, TX and University of Michigan Comprehensive Cancer Center in Ann Arbor, MI. An additional two clinical trial sites are open for enrollment but are not yet actively recruiting patients.

Neo-Kidney Augment Preclinical Program UpdateTengion's lead preclinical program, 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).

Tengion is currently conducting the good laboratory practice (GLP) animal study program required by the FDA to support an Investigational New Drug (IND) filing and initiation of a Phase 1 clinical trial in CKD patients. These GLP studies are consistent with the preclinical animal models already conducted by Tengion, which yielded po
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SOURCE Tengion, Inc.
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