Tengion, Inc. 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). 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.