Vital Therapies Provides Corporate Update
September 13 2016 - 4:01PM
Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company
developing ELAD®, a cell-based therapy targeting the treatment of
acute forms of liver failure, today provided a corporate update.
VTL-308 Enrollment Update
As of today, 14 subjects have been enrolled at
sites in the USA and EU in VTL-308, the Company's phase 3
randomized, controlled, open-label trial, designed to evaluate the
ELAD System in subjects with severe acute alcoholic hepatitis
(sAAH). There are now 24 sites open for enrollment in
VTL-308 in the USA and EU. The Company continues to expect to
announce topline results in mid-2018.
Board Member Faheem Hasnain to Chair New
Commercialization Committee
The Board has formed a Commercialization Committee to formulate
a commercial strategy in anticipation of a positive outcome for its
VTL-308 phase 3 clinical trial. The Committee will be chaired
by recently appointed Board member Faheem Hasnain, formerly
President and CEO of Receptos, Inc. and includes Board members JJ
Bienaime, CEO of BioMarin Pharmaceutical Inc., Cheryl Cohen,
formerly Chief Commercial Officer of Medivation, Inc., Phil
Croxford, CEO of Gamma Medica Inc., and Doug Godshall, formerly CEO
of Heartware Inc. The Company has no insight into the VTL-308
trial results other than enrollment progression, and none is
expected before the anticipated mid-2018 topline readout.
Upcoming Scientific
Presentations
The Company will be presenting two posters and
making related presentations at the 17th International Symposium on
Albumin Dialysis in Liver Disease taking place September 16 through
September 18 in Rostock-Warnemunde, Germany. The first poster
is titled “Hepatic Inflammation and Cellular Therapy.” The
second poster is titled “VTL C3A Cell-Secreted Factors Reduce In
Vitro Hepatocellular Injury via Multiple Mechanisms.” Both
posters and their related presentations will be made available on
Vital Therapies’ web site after they are presented.
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, among
others, statements concerning or implying the timing and conduct of
our clinical trials, including the timing of subject enrollment,
site openings, our anticipation of a positive outcome for our
clinical trials, accomplishment and timing of certain development
goals including regulatory determinations and filings, and our
projected cash runway. Forward-looking statements are based
on management's 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, these
forward-looking statements do not constitute guarantees of future
performance, and you are cautioned not to place undue reliance on
these forward-looking statements. Risks and uncertainties include,
but are not limited to, the success or failure of our clinical
trials and development programs; 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 and
open-label clinical trials; whether or when we begin building any
significant commercial infrastructure; our limited experience in
conducting pivotal clinical trials and significant issues regarding
our clinical trials, including, but not limited to, the successful
opening and the continued participation of clinical sites and their
ongoing adherence to protocols, assumptions regarding enrollment
rates, timing and availability of subjects meeting inclusion and
exclusion criteria, changes to protocols or regulatory
requirements, the ability to comply with and meet applicable laws
and regulations, and unexpected adverse events or safety issues;
and the sufficiency of funding. 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-Q
for the quarter ended June 30, 2016. 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 Kildani
Vice President, Investor Relations and Business Development
858-673-6840
akildani@vitaltherapies.com
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