Eleven Biotherapeutics Announces Data & Safety Monitoring Board (DSMB) Recommendation to Continue Phase 3 Registration Trial ...
June 01 2017 - 8:00AM
Business Wire
Phase 3 Trial Enrollment Exceeds 50%
Company Expects to Complete Patient Enrollment
in 2H2017 and to Report Topline 3-Month Data in 2Q2018
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 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.
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,
212-362-1200hannahd@sternir.com
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