On June 1, 2017 Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported that its Phase 3 registration trial of Vicinium in non-muscle invasive bladder cancer (NMIBC) has exceeded 50% enrollment and that the independent Data and Safety Monitoring Board (DSMB) for the trial has recommended that the trial continue as planned (Press release, Eleven Biotherapeutics, JUN 1, 2017, View Source [SID1234519355]). The DSMB reviewed available data to assess the risk/benefit to patients on drug and recommended that the trial continue without modification. Schedule your 30 min Free 1stOncology Demo! "We are very pleased that the DSMB recommended we continue enrolling our Phase 3 trial after their review of available safety and efficacy data," said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. "Patients with Bacillus Calmette-Guérin (BCG) unresponsive NMIBC have limited therapeutic options and frequently require cystectomies to prevent disease progression. Bladder removal, however, is a serious and life-altering surgery associated with significant morbidity and mortality. Vicinium may offer patients a positive non-surgical risk/benefit profile versus the standard of care. We look forward to advancing our trial as we continue to gain important information about the activity of Vicinium in patients with NMIBC."
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"Urologists are looking for new treatment options for their patients with NMIBC once they stop responding to BCG. Their patients want alternatives to cystectomy. However, the NMIBC treatment landscape has not seen meaningful advances in forty years," commented Arthur DeCillis, Chief Medical Officer of Eleven Biotherapeutics. "With this positive step behind us, we look forward to continuing our Phase 3 registration trial and to reporting topline 3-month data in the second quarter of next year."
Vicinium is a single protein anti-epithelial cell adhesion molecule (anti-EpCAM) antibody fragment fused with Pseudomonas Exotoxin A (ETA) that is designed to specifically target and deliver a potent anti-cancer payload directly into tumor cells. The ongoing Phase 3 registration trial is a single-arm study evaluating Vicinium in patients with high-grade NMIBC, who have previously received two courses of BCG and whose disease is now BCG-unresponsive. Eleven Biotherapeutics plans to enroll 134 patients, at over 70 centers in the United States and Canada. The trial’s primary endpoint is the complete response rate in patients with carcinoma-in-situ (CIS). Secondary endpoints include time to disease recurrence and event free survival. The Company expects to complete patient enrollment in the second half of 2017 and to report 3-month data in the second quarter of 2018.