- ON TRACK FOR RELEASE OF TOPLINE DATA IN THE SECOND QUARTER OF 2015 -
- 200 PATIENTS ENROLLED -
SAN DIEGO, Jan. 30, 2015 (GLOBE NEWSWIRE) -- Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company developing ELAD®, a human cell-based therapy targeting treatment of acute liver failure, today announced achievement of the 200 subject enrollment target in VTI-208, the Company's randomized, controlled, open-label Phase 3 clinical trial in alcohol induced liver decompensation.
"Executing on VTI-208 has been our primary focus over the last two years at about 50 leading hospitals in the U.S., Europe and Australia," said Terry Winters, Ph.D., the Company's Chief Executive Officer and Co-Chairman. "We are grateful to all of our investigators and their staffs who worked diligently to enroll and care for the targeted subjects. We would also like to thank the patients and their families for their willingness to participate in this important trial. Thanks to them, we remain on track to announce topline data in the second quarter of 2015. We will now turn our focus to enrollment in VTI-210, our second Phase 3 trial in severe acute alcoholic hepatitis (AAH), and VTI-212, our phase 2 trial in other forms of acute liver failure."
VTI-208 is a randomized, controlled, open-label Phase 3 clinical trial in alcohol induced liver decompensation. The 200th subject was enrolled on January 28, 2015. A small number of additional subjects already in the active screening process may be enrolled over the next few days. The trial's primary endpoint is overall survival up to at least study day 91.
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 up to at least study day 91. The Company expects topline data from this trial in 2016.
Separately, the Company will be participating in the NASDAQ Closing Bell Ceremony taking place at 4 PM ET on Tuesday, February 24, 2015 at the NASDAQ MarketSite Broadcast Studio, 4 Times Square, New York, NY.
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 regarding the conduct or timing our VTI-208, VTI-210 and VTI-212 clinical trials 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 our 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.