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Tengion Receives MPA Approval of CTA for Neo-Kidney Augment Phase 1 Trial in Sweden
Date:4/1/2013

egeneration of native-like urinary tissue for bladder cancer patients requiring a urinary diversion following bladder removal. The Company plans to initiate a Phase 1 clinical trial in Sweden during the second quarter of 2013 for the Neo-Kidney Augment™, which is designed to prevent or delay dialysis kidney transplantation by increasing renal function in patients with advanced chronic kidney disease. Tengion has worldwide rights to its product candidates.

Forward-Looking Statements

Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements using words such as anticipate, expect, project, intend, plan, believe, words and terms of similar substance and any discussion of future plans, actions, or events generally identify forward-looking statements. Forward-looking statements regarding the Company include but are not limited to (i) plans to develop and commercialize its product candidates, including the Neo-Urinary Conduit and the Neo-Kidney Augment; and (ii) expectations regarding ongoing and planned preclinical studies, clinical trials and related filings or submissions with regulatory authorities.  Although Tengion believes that these statements are based upon reasonable assumptions within the bounds of its knowledge of its business and operations, there are a number of factors that may cause actual results to differ from these statements. Tengion's business is subject to significant risks and uncertainties and there can be no assurance that actual results will not differ materially from expectations.  Factors which could cause actual results to differ materially from expectations include, among others: (i) the U.S. Food and Drug Administration could place the Neo-Urinary Conduit clinical trial on clinical hold; (ii) the Medical Products Agency could place the Neo-Kidney Augment clinical trial on clinical ho
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