Johns Hopkins added as second clinical trial site in Tengion Neo-Urinary Conduit Phase I clinical trial

Sep 10 2010

Tengion, Inc. (Nasdaq: TNGN), a leader in regenerative medicine, announced today it has added The Johns Hopkins Hospital in Baltimore, Maryland as a second clinical trial site for its Phase I clinical trial of the Company's lead product candidate, the Tengion Neo-Urinary Conduit™, in bladder cancer patients requiring bladder removal.  

"The addition of Johns Hopkins as the second clinical trial site is expected to expand enrollment efforts already underway at the University of Chicago site by expanding the pool of potential patients considered for entry in the trial," said Steven Nichtberger, M.D., President and Chief Executive Officer of Tengion.  "With its well-deserved international reputation for clinical excellence, we believe that Johns Hopkins and the Brady Urological Institute is an ideal site for our first clinical trial of this novel technology."

In addition to the participation of the primary investigator, Trinity Bivalacqua, M.D., Ph.D., the addition of Johns Hopkins as a study site allows for the participation of Mark Schoenberg, M.D., Bernard L. Schwartz Distinguished Professor of Urologic Oncology as a sub-investigator in the study.  Dr. Schoenberg, a leader in urologic oncology, has consulted with Tengion on the development of the Neo-Urinary Conduit and the study's surgical protocol for the past 3 years.  His consulting relationship with Tengion and participation as a sub-investigator are being managed by the Johns Hopkins University School of Medicine in accordance with its conflict of interest policies.

The initiation of the Phase I Neo-Urinary Conduit clinical trial at the University of Chicago was announced earlier this year. The study, which initially will enroll up to five patients with bladder cancer following bladder removal (cystectomy), is designed to establish the safety profile for the product as well as to optimize the surgical technique and the ideal post-surgical patient care that is intended to provide superior clinical outcomes.  Utilizing the Company's proprietary organ regeneration technology, the Neo-Urinary Conduit is an implant designed to catalyze regeneration of native-like urinary tissue in patients who require a urinary diversion following cystectomy.  The Neo-Urinary Conduit is produced using the patient's own smooth muscle cells from a routine fat biopsy and not cells from the diseased bladder, eliminating the risk of reintroducing cancerous cells from the bladder into the patient.