Tengion Announces First Implantation Of Neo-Urinary Conduit In Phase I Clinical Trial In Patients With Bladder Cancer
Tengion, Inc. (NASDAQ: TNGN), a leader in regenerative medicine, announced that it has implanted its Neo-Urinary Conduit™ in the first patient as part of the ongoing Phase I clinical trial evaluating the Company’s lead product candidate in bladder cancer patients requiring a urinary diversion following bladder removal. The patient is being treated at the University of Chicago Medical Center by the study’s principal investigator, Gary D. Steinberg, M.D., professor of surgery and director, urologic oncology. The trial is also being conducted at The Johns Hopkins Hospital in Baltimore, Maryland.
“This implantation marks a significant and exciting milestone not only for Tengion, but also for bladder cancer patients and their physicians who are eager for a treatment alternative to the current standard of care,” said Steven Nichtberger, M.D., president and chief executive officer of Tengion.
For many bladder cancer patients who have their cancerous bladders removed, the current standard of care is the surgical creation of a urinary diversion using a segment of the patient’s own bowel tissue. Tengion’s Neo-Urinary Conduit is built from a patient’s own cells obtained from a fat biopsy and is designed to catalyze regeneration of native-like bladder tissue, eliminating the need to harvest bowel tissue or place it in the urinary tract. The purpose of the Neo-Urinary Conduit is to avoid the complications associated with the use of bowel tissue. Complications most often associated with this current treatment include bowel complications, absorption issues, infection, stone formation, and mucus.
The Phase I study, which initially will enroll up to five patients with bladder cancer following bladder removal, is designed to establish the safety profile for the Neo-Urinary Conduit as well as to optimize the surgical technique and the ideal post-surgical patient care that is intended to provide superior clinical outcomes. The surgical procedure may be modified in subsequent patients based on the experience gained by the prior patient(s) enrolled.
The primary safety and efficacy assessment of our Neo-Urinary Conduit will be made at 12 months post-implantation. During this first year, however, patients will be seen frequently by the study investigator and/or designated clinical team: every one to two weeks after hospital discharge through week eight, and then at month 3, 6, 9 and 12. Imaging will be performed at three-month intervals for the first year to examine the neo-organ’s structure, patency and identify any obstructions or other abnormalities. This frequent evaluation and the open-label nature of this study will provide significant ongoing feedback throughout the study.
Further details on the Neo-Urinary Conduit development program and on the Company’s product development portfolio and upcoming milestones will be presented at its Analyst and Investor Meeting on Wednesday, October 27, 2010 at 1:00 to 3:00 pm ET. The live webcast of the event will be available under the Investors section of the Company’s website.
About Bladder Cancer
According to the National Cancer Institute, bladder cancer is the sixth most common form of cancer in the United States with approximately 10,000 cases per year of bladder cancer requiring bladder removal. Following bladder removal, these patients require some form of urinary diversion and most are currently treated by using a segment of bowel tissue to construct a conduit for urine to exit from the body into an ostomy bag.
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Tengion, Inc.