Vital Therapies Announces VTL-308 Reaches Enrollment Target of 150 Subjects
March 22 2018 - 8:01AM
Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company
developing ELAD®, a cell-based therapy targeting the treatment of
acute forms of liver failure, today announced that the VTL-308
phase 3 trial has reached its enrollment target of 150
subjects.
“We are delighted to report that we have reached
target enrollment in VTL-308 before the end of the first quarter as
expected,” said Russell J. Cox, the Company’s Chief Executive
Officer. “We would like to thank the investigators in this
trial and their staffs for enrolling the targeted population and
for providing care to these subjects. We would also like to
thank the patients and their families for participating in this
unique cell therapy trial.”
VTL-308 is the Company's phase 3 randomized,
controlled, open-label trial, designed to evaluate the ELAD System
in subjects with severe alcoholic hepatitis (sAH). The trial,
which enrolled its first subject in May of 2016, was designed based
on learnings from pre-specified and post-hoc analyses of the
Company's VTI-208 clinical trial. Subjects in VTL-308 were
randomized 1:1 to either ELAD plus standard-of-care, or
standard-of-care alone. The primary endpoint is overall
survival through at least 91 days assessed using the Kaplan Meier
statistical method.
The trial’s statistical plan incorporated an
event-driven feature to allow for the extension of enrollment if a
preliminary review of blinded data from VTL-308 was found to be
inconsistent with prior expectations. During the first
quarter of 2018, a review by independent statisticians concluded
that the overall event rate experienced in VTL-308 subjects through
year end 2017 was consistent with the trial’s original statistical
plan, and therefore recommended the Company retain the trial’s
original enrollment target of 150. The Company remains on
track to report topline results for VTL-308 in the third quarter,
likely in September.
About Vital Therapies, Inc.
Vital Therapies, Inc. is a biotherapeutic
company developing a cell-based therapy targeting the treatment of
acute forms of liver failure. The Company’s ELAD System is an
extracorporeal human allogeneic cellular liver therapy currently in
phase 3 clinical trials. Vital Therapies, Inc. is based in San
Diego, California. Vital Therapies® and ELAD® are trademarks
of Vital Therapies, Inc.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements include statements
concerning or implying the success of our clinical trials,
expectations regarding the achievement of the targeted number of
events and the timing of the release of topline data.
Forward-looking statements are based on current expectations and
are subject to various risks and uncertainties that could cause
actual results to differ materially and adversely from those
expressed or implied by such forward-looking statements.
Accordingly, forward-looking statements do not constitute
guarantees of future performance, and you are cautioned not to
place undue reliance on forward-looking statements.
Risks and uncertainties include, but are not
limited to, the success or failure of our clinical trials; whether
a single phase 3 clinical trial will be sufficient to support U.S.
Food and Drug Administration approval of a biologics license
application or whether the FDA will require us to conduct
additional clinical trials; difficulty obtaining regulatory
approval in the United States or Europe, in particular for a
combination product with open-label clinical trials; final event
rates may vary from earlier statistical projections and we may
experience delays releasing topline data due delays in obtaining
data, completing quality reviews and locking the data for all
clinical sites within our expected timeframes. There can be no
assurance that data from any of our clinical trials will be
sufficient to support an application for marketing in any country
or that any such application will ever be approved.
These and other risks regarding our business are
described in detail in our Securities and Exchange Commission
filings, including in our Quarterly Report on Form 10-K for the
quarter ended December 31, 2017. These forward-looking
statements speak only as of the date hereof, and Vital Therapies,
Inc. disclaims any obligation to update these statements except as
may be required by law.
Contact: Vital Therapies, Inc. Al KildaniVice President,
Investor Relations and Business Development
858-673-6840akildani@vitaltherapies.com
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