SAN DIEGO, CA, USA I May 23, 2016 I Vital Therapies, Inc. (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.
SOURCE: Vital Therapies
Post Views: 350
SAN DIEGO, CA, USA I May 23, 2016 I Vital Therapies, Inc. (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.
SOURCE: Vital Therapies
Post Views: 350
