Market Overview

Tengion Provides Update on Neo-Urinary Conduit Clinical Trial

Share:

Tengion, Inc. (Nasdaq: TNGN) today provided an update on the clinical trial of the Company's lead clinical product candidate, the Neo-Urinary Conduit™, for use in bladder cancer patients requiring a urinary diversion following bladder removal.

Tengion is continuing to work with investigators to optimize the surgical approach as part of its ongoing clinical trial of the Neo-Urinary Conduit in patients with bladder cancer and is working closely with clinical investigators, the Data Safety Monitoring Board and the U.S. Food and Drug Administration to advance the study.

"As planned, we have reviewed clinical data from our ongoing trial with the investigators, the DSMB, and the FDA," said Sunita Sheth, M.D., Chief Medical Officer and Vice President Clinical and Regulatory Affairs of Tengion. "Based on these discussions, a plan has been developed to collect additional clinical data while modifying the surgical approach for future implants. We expect to submit these data and changes to the FDA in the third quarter, prior to enrolling additional patients in the trial."

Posted-In: News FDA

 

Related Articles (TNGN)

View Comments and Join the Discussion!

Partner Center