Tengion, Inc. Announces Continued Clinical Progress on Key Milestones for Neo-Urinary Conduit(TM)
June 11, 2012 at 01:30 pm
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Tengion, Inc. announced continued clinical progress on key milestones for the ongoing Phase 1 trial of the Company's most advanced product candidate, the Neo-Urinary Conduit. The company announced that it has successfully implanted the fifth patient in the ongoing Phase 1 clinical trial of its most advanced product candidate, the Neo-Urinary Conduit, for use in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). The trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit in up to 10 patients, as well as to translate the surgical procedure successfully used in preclinical animal models into clinical trials with human patients. Following a positive meeting with the Data Safety Monitoring Board, Tengion is proceeding with concurrent enrollment of the next two patients, the sixth and seventh patients in the clinical trial. Assuming appropriate safety data, the Company anticipates commencement of efforts to enroll the remaining three patients approximately six weeks after implant of patients six and seven, thereby allowing the Company to achieve its stated objective of completing implantation of up to 10 patients by the end of 2012. The company also announced that the trial is being expanded to include four additional centers. In addition to University of Chicago Medical Center and The Johns Hopkins Hospital in Baltimore, MD, surgeons will be trained on the surgical implantation procedure at Memorial Sloan-Kettering Cancer Center in New York, NY; Baylor Charles A. Sammons Cancer Center in Dallas, TX; University of Michigan Comprehensive Cancer Center in Ann Arbor, MI and a fourth site in Boston, MA. The last three patients in the Phase 1 clinical trial can be enrolled in any of the six sites.
Tengion, Inc. is a regenerative medicine company focused on discovering, developing, manufacturing and commercializing a range of neo-organs, or products composed of living cells, with or without synthetic or natural materials, implanted or injected into the body to engraft into, regenerate, or replace a damaged tissue or organ. Â The Company, by using its Organ Regeneration Platform, it creates neo-organs using patientâs own cells. Â The Company, based on its clinical and preclinical experience is leveraging its Organ Regeneration Platform to develop Neo-Kidney Augment for patients with advanced chronic kidney disease and Neo-Urinary Conduit for bladder cancer patients who are in need of a urinary diversion. The Companyâs product candidates are intended to delay or eliminate the need for chronic disease therapies, organ transplantation, and the administration of anti-rejection medications.