Eleven Biotherapeutics Announces Data and Safety Monitoring Board (DSMB) Recommendation to Continue Phase 3 Registration Trial with Vicinium™ in Non-Muscle Invasive Bladder Cancer Based on Review of Safety and Efficacy Data
Phase 3 Trial Enrollment Exceeds 50%
Company Expects to Complete Patient Enrollment in 2H2017 and to Report Topline 3-Month Data in 2Q2018
"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
"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
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.
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"project," "target," "potential," "will," "would," "could," "should,"
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Reform Act of 1995. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including: the uncertainties inherent in the
initiation and conduct of clinical trials, our ability to successfully
develop our product candidates and complete our planned clinical
programs, our ability to obtain marketing approvals for our product
candidates, expectations regarding our ongoing clinical trials,
availability and timing of data from clinical trials, whether interim
results from a clinical trial will be predictive of the final results of
the trial or results of early clinical studies will be indicative of the
results of future studies, the adequacy of any clinical models,
expectations regarding regulatory approvals and other factors discussed
in the "Risk Factors" section of the Company's Annual Report on Form
10-K, Quarterly Reports on Form 10-Q and other reports filed with the
Stern Investor Relations, Inc.
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