Market Overview

Vital Therapies Announces First Subject Enrolled In VTI-210 And Provides Update On Enrollment In VTI-208


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.

Posted-In: News Press Releases


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