SAN DIEGO, Jan. 12, 2015 (GLOBE NEWSWIRE) -- Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company developing ELAD®, a cell-based therapy targeting treatment of acute liver failure, today provided an update on its clinical trial programs and regulatory matters.
As of today, 193 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. Forty-six clinical sites are now open in the USA, UK, Spain and Australia. The Company expects to complete enrollment around the end of January and remains on track to announce topline data in the second quarter of 2015. The primary endpoint of VTI-208 is overall survival through at least study day 91. If VTI-208 is statistically and clinically successful, the Company plans to submit a Biologics License Application, or BLA, to the Food and Drug Administration (FDA) in the first half of 2016.
The Company continues to expect topline data from both the VTI-210 and VTI-212 clinical trials in 2016. VTI-210, the Company's second Phase 3 trial, is a randomized, controlled, open-label study evaluating the ELAD System in severe acute alcoholic hepatitis (AAH) patients who have failed standard therapy. VTI-212 is a single-arm Phase 2 trial, evaluating the ELAD System in patients with either fulminant hepatic failure or surgery-induced liver failure.
On the regulatory front, the Company recently received approval of its German Clinical Trial Application (CTA) and can now begin to open sites and enroll subjects in its VTI-210 trial. The Company expects to open up to 10 sites in Germany for VTI-210 in the next year, which will augment the existing VTI-210 sites in the USA, UK and Spain.
Additionally, the Company recently received regulatory guidance responses from the FDA concerning its submission regarding chemistry, manufacturing, and controls topics. The Company believes that this guidance, which covered both the biologic and delivery components of ELAD, is consistent with the Company's current plans as well as prior interactions with the agency.
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 and regulatory submissions. 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.