Policy & Regulation
Eleven Biotherapeutics Completes Enrollment in Phase 3 Trial of Vicinium in Certain NMIBC Patients
13 March 2018 - - Cambridge, Massachusetts-based clinical oncology company Eleven Biotherapeutics, Inc. (NASDAQ: EBIO) has completed enrollment in the VISTA Phase 3 registration trial of its lead product candidate, Vicinium, in patients with non-muscle invasive bladder cancer (NMIBC) who have been previously treated with bacillus Calmette-Guérin, the company said.
The VISTA trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicinium in patients with high-risk non-muscle invasive bladder cancer (NMIBC) that is carcinoma in situ (CIS) or papillary, who have been previously treated with bacillus Calmette-Guérin.
The primary endpoint of the trial is the complete response rate in patients with CIS with or without papillary disease.
Patients in the study receive locally administered Vicinium twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years.
Vicinium, a fusion protein designed to be a next-generation antibody-drug conjugate (ADC), specifically targets the epithelial cell adhesion molecule (EpCAM) antigens on the surface of bladder cancer cells to deliver a potent cytotoxin to those cells.
Eleven Biotherapeutics is advancing novel product candidates based upon the company's targeted protein therapeutics (TPTs) platform.
The company's TPTs incorporate a tumor-targeting antibody fragment and a protein cytotoxic payload into a single protein molecule in order to achieve focused tumor cell killing.


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