Phase 3 Trial Enrollment Exceeds 50%
Company Expects to Complete Patient Enrollment in 2H2017 and to
Report Topline 3-Month Data in 2Q2018
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
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, today
announced 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. The DSMB reviewed
available data to assess the risk/benefit to patients on drug and
recommended that the trial continue without modification.
"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."
"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
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.
About Eleven Biotherapeutics
Eleven Biotherapeutics, Inc. is a late-stage clinical oncology company
advancing a broad pipeline of novel product candidates based upon the
Company's TPT 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. The Company
believes its TPT approach offers significant advantages in treating
cancer over existing ADC technologies. The Company believes its TPTs
provide effective tumor targeting with broader cancer cell-killing
properties than are achievable with small molecule payloads that require
tumor cell proliferation and face multi-drug resistance mechanisms.
Additionally, the Company believes that its TPT's cancer cell-killing
properties promote an anti-tumor immune response that will potentially
combine well with immuno-oncology drugs such as checkpoint inhibitors.
For more information please refer to the Company's website at www.elevenbio.com.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, the Company's strategy, future
operations, and other statements containing the words "anticipate,"
"believe," "estimate," "expect," "intend," "may," "plan," "predict,"
"project," "target," "potential," "will," "would," "could," "should,"
"continue," and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation
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
Securities and Exchange Commission. In addition, the forward-looking
statements included in this press release represent the Company's views
as of the date hereof. The Company anticipates that subsequent events
and developments will cause the Company's views to change. However,
while the Company may elect to update these forward-looking statements
at some point in the future, the Company specifically disclaims any
obligation to do so. These forward-looking statements should not be
relied upon as representing the Company's views as of any date
subsequent to the date hereof.
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Stern Investor Relations, Inc.
Hannah Deresiewicz, 212-362-1200
Source: Eleven Biotherapeutics, Inc.
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