SAN DIEGO, Nov. 18, 2015 (GLOBE NEWSWIRE) -- Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company developing ELAD®, a cell-based therapy targeting the treatment of liver failure, announced two presentations were given this week at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Disease (AASLD), in San Francisco, CA.
Monday at the AASLD meeting, results of the VTI-208 clinical trial were presented in the late breaker session by Principal Investigator David J. Reich, MD, Professor and Chief of the Division of Multi-organ Transplantation and Hepatobiliary Surgery, and Vice Chairman of the Department of Surgery, at Drexel University College of Medicine and Hahnemann University Hospital in Philadelphia. The AASLD meeting is one of the largest meetings dedicated to the study of the liver and attracts about 10,000 of the leading liver specialists in the world.
Dr. Reich's presentation is now available at http://ir.vitaltherapies.com under the "Clinical Publications and Presentations" section.
Also at the AASLD meeting, a poster, titled "ELAD VTL C3A Cells May Impact Liver Regeneration through Secreted Factors," was presented yesterday that describes further laboratory research conducted by the Company into ELAD's possible mechanism of action. The Company previously reported results from laboratory studies demonstrating that VTL C3A cells can produce factors reported in the literature to modulate the inflammation that is a signature of alcohol induced liver decompensation (AILD). The AASLD poster presents new laboratory data on the in vitro function of some of these factors indicating that they may play a role in prevention of apoptosis (programmed cell death), stimulation of cell growth and/or proliferation, and stimulation of vascular regeneration. It should be noted that, while these factors have been studied in the laboratory, the Company has yet to demonstrate their activity in patients or correlate them with clinical outcomes.
The VTL C3A factors identified in these laboratory studies and their purported function, as described in the literature, include:
- Amphiregulin – a factor critical to the modulation of apoptosis in animal models of liver regeneration;
- Vascular endothelial growth factor – a well-characterized promoter of blood vessel formation in damaged tissue;
- Transforming growth factor alpha – a potent mitogen, or substance which promotes cell division;
- Hepatocyte growth factor – the primary factor associated with the proliferation of hepatocytes following liver resection;
- Stem cell factor – shown in vitro to induce proliferation in cholangiocytes and hepatocytes, and
- Erythropoietin - shown to work synergistically with granulocyte colony-stimulating factor to increase survival in patients with decompensated cirrhosis.
This poster is now available at http://ir.vitaltherapies.com under the "Clinical Publications and Presentations" section.
Upcoming Investor Presentation
The Company will be presenting at the Jefferies Autumn 2015 Global Healthcare Conference in London on Thursday, November 19, 2015 at 4:00 PM local time (11:00 AM ET). A live webcast of the Company's presentation will be available on the Investor Relations page of the Company's website at: http://ir.vitaltherapies.com/. The webcast will be archived for approximately two weeks following the live presentation.
About VTI-208 and VTI-208E
VTI-208 was a phase 3 randomized, controlled, open-label trial, evaluating the ELAD System in subjects with AILD. The primary endpoint was overall survival through at least 91 days assessed using the Kaplan Meier statistical method, and the secondary endpoint was proportion of survivors at study days 28 and 91. The trial enrolled 203 subjects over 22 months with 96 subjects randomized to the treated group and 107 randomized to the control group. VTI-208E, an extension study, assesses subject outcomes for five years after enrollment in VTI-208. Results of the VTI-208 clinical trial, incorporating VTI-208E survival data through July 30, 2015, showed that the trial failed to reach its primary or secondary endpoints.
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. The Liver Meeting® and AASLD are registered trademarks of the American Association for the Study of Liver Diseases.
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 the mechanisms of action of our ELAD System and analysis of laboratory data from laboratory studies conducted by Vital Therapies. 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 complexity of ELAD's potential mechanism of action, whether we are able to prove ELAD's potential mechanism of action and/or elucidate the exact role of any given pathway, in particular, given that our research on mechanism of action is based on hypotheses derived from laboratory studies and needs correlation in in vivo studies and patient outcomes, and whether we are able to conduct additional testing to confirm the potential mechanism of action and whether this additional testing, if any, actually confirms our hypotheses. 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.