Tengion, Inc. announced advances for its two lead programs, the Neo-Urinary Conduit and Neo-Kidney Augment. Tengion announced that it has successfully implanted the seventh patient in the ongoing Phase 1 clinical trial of its most advanced product candidate, the Neo-Urinary Conduit, for use in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). The trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit in up to 10 patients, as well as to translate the surgical procedure successfully used in preclinical animal models into clinical trials with human patients.

The Neo-Urinary Conduit offers patients potential improvements over the standard of care, including a shorter and less complex surgical procedure, improved recovery times and faster hospital discharges, as well as no evidence of the typical post-operative co-morbidities associated with the current standard of care. Tengion is proceeding with concurrent enrollment of the remaining three patients in the Phase 1 trial. There are now six centers open for recruiting patients for this clinical trial and Tengion anticipates that it will implant 10 patients by the end of the first quarter of 2013, which would complete enrollment in the trial.

Tengion also announced that it has filed a Clinical Trial Application (CTA) with the Medical Products Agency (MPA) in Sweden to initiate a Phase 1 clinical trial to evaluate safety and delivery of its Neo-Kidney Augment product in up to five patients with chronic kidney disease (CKD). 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 CKD. Following MPA approval of the CTA, Tengion expects to initiate a Phase 1 trial in Sweden in the second quarter of 2013.

Tengion also expects to submit an Investigational New Drug (IND) filing for the Neo-Kidney Augment to the U.S. Food and Drug Administration (FDA) during the second quarter of 2013. Following FDA approval of the IND, Tengion expects to initiate a Phase 1 clinical trial in the U.S. in the fourth quarter of 2013 and anticipates that this trial will provide initial human proof-of-concept data in 2014. Tengion is currently conducting the good laboratory practice (GLP) animal study program required by the FDA to support the 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 positive data demonstrating slowing of kidney disease progression and improved survival.