Vital Therapies Enrolls First Subject In VTL-308
SAN DIEGO, May 23, 2016 (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 announced the first subject was recently enrolled in its phase 3 trial designated VTL-308. There are now ten sites open for enrollment in VTL-308.
Additionally, the Company will be presenting at the Jefferies Healthcare Conference on June 10, 2016 at 12:30 PM ET in New York City.
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. Subjects must be under the age of 50, have a MELD score under 30, an INR of 2.5 or below, a creatinine level below 1.3 mg/dL, and a bilirubin level of at least 16 mg/dL. 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 among roughly 40 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 of subject enrollment, site openings, accomplishment and timing of certain development goals including 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, 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 March 31, 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: Vital Therapies, Inc. Al Kildani Vice President, Investor Relations and Business Development 858-673-6840 akildani@vitaltherapies.com