Tengion is a clinical-stage regenerative medicine company currently focused on developing its Organ Regeneration Platform to harness the regenerative pathways of the body to regenerate a range of tissues with the goal of delaying or eliminating the need for chronic disease therapies, and even organ transplantation. Its most advanced product candidate is Neo-Urinary Conduit, an implant that is intended to catalyze regeneration of urinary tissue in patients with bladder cancer, following bladder removal.
The Neo-Urinary Conduit is a combination of a patient's own cells and a bioabsorbable scaffold that is intended to catalyze regeneration of a native-like urinary tissue conduit, passively transporting urine from the ureters through a hole in the abdomen into a standard ostomy bag. Standard procedure now uses bowel tissue to construct a conduit for urine to exit from the body. There are over 20,000 such procedures performed annually in the United States and Europe.
The company reported today continued clinical progress on key milestones for the ongoing Phase I trial of its Neo-Urinary Conduit. The trial is designed to assess the safety and preliminary efficacy of the Conduit in up to 10 patients, as well as to translate the surgical procedure that was used in successful preclinical animal models into clinical trials with human patients.
Tengion successfully implanted the fifth patient last month using the same surgical procedure as it did with the fourth patient. It now believes that it has successfully defined the surgical procedure for all future patients. This places Tengion in a position to accelerate enrollment in the Phase I trial. Following a meeting with the FDA's Data Safety Monitoring Board, Tengion is proceeding with the enrollment of patients six and seven in the clinical trial. The company anticipates the beginning of efforts to enroll the remaining three patients in the trial within six weeks.
For additional information about Tengion, the Neo-Urinary Conduit and its other product candidates, please visit the company's website at www.tengion.com
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