Biotherapeutic company, Vital Therapies, has completed the enrollment of 200 patients for the company’s phase 3 clinical trial, VTI-208, designed to evaluate human cell-based therapy for the treatment of acute liver failure. The ELAD System, an investigational human cell-based, bio-artificial liver support system that operates outside the body, is indicated for patients who suffer from alcohol induced liver decompensation.
Within this randomized, controlled and open-label phase 3 clinical trial, the investigators from Vital Therapies are evaluating the efficacy of ELAD in patients with alcohol induced liver decompensation. “Executing on VTI-208 has been our primary focus over the last two years at about 50 leading hospitals in the U.S., Europe and Australia,” explained the CEO and co-chairman of Vital Therapies, Terry Winters, PhD.
The company completed enrollment of 200 patients at the end of January, and is considering adding more participants in the near future. The primary endpoint that will be assessed by the research team is overall survival until at least the 91st day of study while being treated with the ELAD System.
“We are grateful to all of our investigators and their staffs who worked diligently to enroll and care for the targeted subjects,” added Winters. “We would also like to thank the patients and their families for their willingness to participate in this important trial. Thanks to them, we remain on track to announce topline data in the second quarter of 2015. We will now turn our focus to enrollment in VTI-210, our second phase 3 trial in severe acute alcoholic hepatitis (AAH), and VTI-212, our phase 2 trial in other forms of acute liver failure.”
In addition to treating alcohol induced liver decompensation patients, the company is developing treatment for other liver conditions using cell-based therapies, such as severe acute alcoholic hepatitis. Vital Therapies is also conducting another phase 3 trial to study the effects of the ELAD system in patients who suffer from the condition.
The VTI-210 trial in AAH patients, which is a randomized, controlled, open-label study, is focused on patients who have tried and failed to be treated with standard therapies, and will enroll at least 150 participants. The company is planning on announcing topline results of the trial next year, with a primary endpoint similar to the VTI-208 study.
Vital Therapies is also scheduled to attend the NASDAQ Closing Bell Ceremony, on Tuesday, February 24, 2015, at the NASDAQ MarketSite Broadcast Studio, in New York.