Vital Therapies Announces That Topline Results of VTL-308 Fail to Achieve Primary and Secondary Endpoints of Improvement in S...
September 12 2018 - 4:00AM
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, while there was
a numerical improvement in survival in the ELAD-treated group
between three months and one year following randomization, the
VTL-308 study failed to meet the primary endpoint of a significant
improvement in overall survival through at least 91 days assessed
using the Kaplan Meier statistical method. The secondary
endpoint of proportion of survivors at study day 91 also showed no
statistically significant difference between the groups.
In light of these results, the Company does not
believe the ELAD System can be approved in the United States or
European Union, if ever, without additional clinical trials that
would require substantial capital and time to complete.
Consequently, the Company will cease any further development of the
ELAD System and explore strategic options.
“Although we did not achieve the outcome we were
hoping for, we would like to thank those who made this trial
possible, including our investigators and their staffs, the
patients who were enrolled and their families, and all Vital
Therapies employees,” said Russell J. Cox, the Company’s Chief
Executive Officer.
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. Risks regarding our business are
described in detail in our Securities and Exchange Commission
filings, including in our Annual Report on Form 10-Q for the
quarter ended June 30, 2018. 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.
Investor Contact: Vital Therapies, Inc. Investor Relations
858-673-6840InvestorRelations@vitaltherapies.com
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