SAN DIEGO, Dec. 8, 2014 (GLOBE NEWSWIRE) -- Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company developing ELAD®, a cell-based therapy targeting treatment of acute liver failure, today announced enrollment of the first subject in its Phase 3 trial in severe acute alcoholic hepatitis (AAH) designated VTI-210. The subject was enrolled at Royal Free Hospital in London, United Kingdom.
"There is a significant unmet need for new therapies addressing severe acute alcoholic hepatitis, a life-threatening condition with limited treatment options currently," said Dr. Rajiv Jalan, Professor of Hepatology at the University College London Institute for Liver and Digestive Health and Royal Free Hospital, and principal investigator for the study. "We are excited to be involved in VTI-210, a very important clinical trial with an innovative design that will evaluate the potential benefits of the ELAD bio-artificial liver support system in a particularly sick population of acute alcoholic hepatitis patients who have failed standard therapy and have high mortality rates."
"We are proud to have an institution of the caliber of Royal Free Hospital participating in this important Phase 3 trial," said Dr. Jan Stange, the Company's Chief Medical Officer. "Having met our goal of enrolling the first VTI-210 subject before year-end, we look forward to ramping up enrollment in this trial once VTI-208, our Phase 3 trial in alcohol-induced liver decompensation, is fully enrolled."
VTI-210, the Company's second Phase 3 trial, is a randomized, controlled, open-label study evaluating the ELAD system in severe AAH patients who have failed standard therapy. This trial targets enrollment of a minimum of 150 subjects with a primary endpoint of overall survival with a minimum follow up period of 90 days. The Company expects topline data from this trial in 2016.
As of today, 182 of a targeted 200 subjects have been enrolled in VTI-208, the Company's randomized, controlled, open-label Phase 3 clinical trial in alcohol induced liver decompensation. The primary endpoint of VTI-208 is overall survival with a minimum follow up period of 90 days. The Company remains on track to complete enrollment around the end of the year and announce topline data in the second quarter of 2015. Fifty clinical sites are now open in the USA, UK, Spain and Australia.
About Vital Therapies, Inc.
Vital Therapies, Inc. is a biotherapeutic company developing a cell-based therapy targeting treatment of acute liver failure. The Company's lead product-candidate, the ELAD System, is an extracorporeal bio-artificial 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 expectations for our ability to undertake certain development activities such as clinical trial enrollment and the conduct of our clinical trials (including VTI 208 and VTI 210) and the timing of data release. Forward-looking statements are based on management's current, preliminary 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 Company's dependence on the success of its ELAD system, its sole product candidate; the success or failure of its clinical trials and development programs; difficulty obtaining regulatory approval in the United States or Europe, in particular for a combination product; and the Company's limited experience in conducting pivotal clinical trials and significant issues regarding its 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. These and other risks regarding our business are described in detail in our SEC filings, including in our recently filed Quarterly Report on Form 10-Q for the quarter ended September 30, 2014. 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.