SAN DIEGO, Nov. 19, 2015 (GLOBE NEWSWIRE) -- Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company developing ELAD®, a cell-based therapy targeting the treatment of liver failure, announced that it has received written responses from the FDA to its Type C meeting request on the planned VTL-308 phase 3 clinical trial.
At the FDA's suggestion, the Company has incorporated an event-driven feature into the trial design consistent with the primary endpoint of overall survival. Under the modified design, enrollment will continue until at least 150 subjects have been enrolled and 55 events have occurred, consistent with the event rate seen in the target subpopulation from VTI-208.
In light of the FDA's guidance on trial design and other topics, the VTL-308 program remains on track. Clinical sites are in the process of opening, with enrollment of the first subject expected in the first half of 2016, and final data anticipated in mid-2018.
VTL-308 is a planned phase 3 randomized, controlled, open-label trial, designed to evaluate the ELAD System in subjects with alcohol induced liver disease (AILD) who meet criteria based on learnings from pre-specified and post-hoc analyses of the recently completed 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 United States, the United Kingdom, Ireland, Germany and Spain, with first patient enrollment projected to occur in the first half of 2016, and final data expected around mid-2018.
About Vital Therapies, Inc.
Vital Therapies, Inc. is a biotherapeutic company developing a cell-based therapy targeting the treatment 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.
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 number of patients and timing of patient enrollment, site openings, data release, 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, the success or failure of our clinical trials and development programs; whether a single phase 3 clinical trial will be sufficient to support FDA approval of a biologics license application or whether the FDA will require us to conduct additional clinical trials; difficulty obtaining regulatory approval 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 impact of the failure of the Company's prior VTI-208 clinical trial in AILD to achieve favorable results, 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 Annual Report on Form 10-K for the year ended December 31, 2014 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2015. 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 firstname.lastname@example.org
Source:Vital Therapies, Inc.