Tengion completes FDA Pre-IND meeting for Neo-Kidney Augment preclinical program

Apr 18 2012

Tengion, Inc. (NASDAQ: TNGN), a leader in regenerative medicine, today announced that it recently completed a successful Pre-IND meeting with the U.S. Food and Drug Administration (FDA) for its lead preclinical program, the Neo-Kidney Augment™. The FDA and the Company have agreed on a good laboratory practice (GLP) animal study program required to support an Investigational New Drug (IND) filing and initiation of a Phase 1 clinical trial in chronic kidney disease (CKD) patients. The Company anticipates that it will submit an IND filing for the product candidate during the first half of 2013 and that its Phase 1 trial will provide initial human proof-of-concept data in 2014.

"We are very pleased with the progress of the Neo-Kidney Augment program. Our successful interactions with the FDA are a testament to the high quality of work done by our scientific team and have led to plans for an IND filing followed by a Phase 1 clinical trial to be conducted in CKD patients that could lead to human proof-of-concept data," said John L. Miclot, Tengion's President and Chief Executive Officer. "We are focused on realizing the key milestones for both of our lead programs in order to help patients as well as create value for all of our stakeholders."

In addition to the Neo-Kidney Augment, the Company is developing the Neo-Urinary Conduit™, which is in a Phase 1 trial in bladder cancer patients and is intended to regenerate native-like urinary tissue for patients requiring a urinary diversion following bladder removal (cystectomy).