SAN DIEGO, Jan. 09, 2017 (GLOBE NEWSWIRE) — Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company developing ELAD®, a cell-based therapy targeting the treatment of acute forms of liver failure, today provided a corporate update.
As of yesterday, 38 subjects have been enrolled at sites in the USA and EU in VTL-308, the Company’s phase 3 randomized, controlled, open-label trial, designed to evaluate the ELAD System in subjects with severe acute alcoholic hepatitis (sAAH). This compares with 20 subjects enrolled as of November 3, 2016, the Company’s prior corporate update.
There are now 38 sites open for enrollment in VTL-308 in the USA and EU. The Company is targeting the opening of 50 clinical sites in the United States and Europe, and continues to expect to announce topline results in mid-2018.
In further news, the Company noted that a paper entitled “Early Change in Bilirubin Level (ECBL) as a Surrogate for Outcome in ELAD Clinical Study of Severe Alcoholic Hepatitis (sAH)” has been accepted for oral presentation at the Asian Pacific Association for the Study of the Liver (APASL) meeting in Shanghai, China, on February 19, 2017. The paper will be presented by Dr. Tarek Hassanein, a physician investigator in the VTI-208 and VTL-308 clinical trials from the Southern California Research Center, Coronado, CA, United States.
About VTL-308
VTL-308 is the Company’s phase 3 randomized, controlled, open-label trial, designed to evaluate the ELAD System in subjects with severe acute alcoholic hepatitis (sAAH) who meet criteria based on learnings from pre-specified and post-hoc analyses of the Company’s VTI-208 clinical trial. The primary endpoint is overall survival through at least 91 days assessed using the Kaplan Meier statistical method. The trial is intended to enroll a minimum of 150 subjects, who will be randomized 1:1 to either ELAD therapy plus standard-of-care, or standard-of-care alone. The Company expects to enroll subjects at about 50 sites in the US and EU. Topline results from VTL-308 are anticipated in mid-2018.
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. Forward-looking statements include, among others, statements concerning or implying the timing and conduct of our clinical trials, including the timing and rate of subject enrollment, site openings, and the accomplishment and timing of regulatory determinations and filings. Forward-looking statements are based on management’s current 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 rate of subject enrollment in VTL-308; the number of subjects that will need to be enrolled in the trial; difficulty obtaining and maintaining regulatory approvals in the United States or Europe, in particular for a combination product and open-label clinical trials; our limited experience in conducting pivotal clinical trials and significant issues regarding our 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; and the sufficiency of funding. There can be no assurance that data from any of our clinical trials will be sufficient to support an application for marketing in any country or that any such application will ever be approved. These and other risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. 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.
CONTACT: Contact: Vital Therapies, Inc. Al Kildani Vice President, Investor Relations and Business Development 858-673-6840 akildani@vitaltherapies.com
