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

WINSTON-SALEM, N.C., April 1, 2013 /PRNewswire/ -- Tengion, Inc. (OTCQB: TNGN), a leader in regenerative medicine, today announced the acceptance of the Company's Clinical Trial Application (CTA) filed with the Medical Products Agency (MPA) in Sweden to initiate a Phase 1 clinical trial to evaluate the safety and delivery of its Neo-Kidney Augment™ product in up to five patients with advanced chronic kidney disease (CKD). 

"We are excited to have received MPA approval for the Neo-Kidney Augment Phase 1 trial in Sweden and expect to initiate the trial this quarter. We will use the data from this trial to establish safety and a delivery approach for our planned U.S. Phase 1 trial, which we expect to start in the fourth quarter of 2013. We are confident that the Neo-Kidney Augment can truly benefit CKD patients in need of transformative, life-changing technologies," said John L. Miclot , President and Chief Executive Officer of Tengion.

Tengion's 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 CKD patients. The Phase 1 trial will involve delivery of an active regenerative dose of Neo-Kidney Augment in patients with CKD. The trial is expected to enroll up to 5 patients in 2013 and will follow each patient for up to 2 years.

This CTA acceptance follows Tengion's inspection by an Official Qualified Person for regulatory compliance with European Medicines Agency standards for clinical manufacturing, processes, management, and quality programs. Following the successful inspection, the Company was issued a Declaration of Compliance to enable clinical production of the Neo-Kidney Augment at its cGMP manufacturing facility located in Winston-Salem, North Carolina.

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