SAN DIEGO, Sept. 13, 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 provided a corporate update.
VTL-308 Enrollment Update
As of today, 14 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). There are now 24 sites open for enrollment in VTL-308 in the USA and EU. The Company continues to expect to announce topline results in mid-2018.
Board Member Faheem Hasnain to Chair New Commercialization Committee
The Board has formed a Commercialization Committee to formulate a commercial strategy in anticipation of a positive outcome for its VTL-308 phase 3 clinical trial. The Committee will be chaired by recently appointed Board member Faheem Hasnain, formerly President and CEO of Receptos, Inc. and includes Board members JJ Bienaime, CEO of BioMarin Pharmaceutical Inc., Cheryl Cohen, formerly Chief Commercial Officer of Medivation, Inc., Phil Croxford, CEO of Gamma Medica Inc., and Doug Godshall, formerly CEO of Heartware Inc. The Company has no insight into the VTL-308 trial results other than enrollment progression, and none is expected before the anticipated mid-2018 topline readout.
Upcoming Scientific Presentations
The Company will be presenting two posters and making related presentations at the 17th International Symposium on Albumin Dialysis in Liver Disease taking place September 16 through September 18 in Rostock-Warnemunde, Germany. The first poster is titled “Hepatic Inflammation and Cellular Therapy.” The second poster is titled “VTL C3A Cell-Secreted Factors Reduce In Vitro Hepatocellular Injury via Multiple Mechanisms.” Both posters and their related presentations will be made available on Vital Therapies’ web site after they are presented.
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.
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, our anticipation of a positive outcome for our clinical trials, accomplishment and timing of certain development goals including regulatory determinations and filings, and our projected cash runway. 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 U.S. Food and Drug Administration 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; whether or when we begin building any significant commercial infrastructure; 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 June 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.
Last updated on: 15/09/2016
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