SAN DIEGO, CA, USA I July 9, 2014 I Vital Therapies, Inc. (VTL), a biotherapeutic company developing ELAD(R), a cell-based therapy targeting treatment of acute liver failure, is providing this update on the status of its clinical trials and the European Medical Agency’s (EMA) response to its request for advice through the Scientific Advice Working Party (SAWP) process.
As of today, 123 of a targeted 200 subjects have been enrolled in VTI-208, our randomized, controlled Phase 3 clinical trial in alcohol induced liver decompensation. Enrollment rates remain consistent with prior projections, and preliminary results are expected in the first half of 2015. Forty-eight clinical sites are now open in the USA, UK, Spain and Australia, and 37 sites have enrolled at least one subject.
Our second randomized, controlled, Phase 3 clinical trial, VTI-210, is studying the use of ELAD in subjects with acute alcoholic hepatitis (AAH) who have failed steroid therapy. As part of the process for preparing for a possible European Marketing Authorization Application (MAA) based primarily on VTI-210, we submitted a request earlier this year for SAWP advice on topics relating to the production and testing section of a future MAA, and on aspects of VTI-210 protocol design.
On June 30, 2014, we received detailed written responses from SAWP which provide constructive written guidance on both topics. We believe that the production and testing guidance is consistent with the company’s prior interactions with regulatory agencies and should pose no delays to existing timelines. The SAWP guidance also permitted the stratification of subjects into groups based on AAH diagnosis either by biopsy or by clinical grounds without biopsy. We plan to amend the protocol consistent with this guidance, and also to explore an event-driven design with a minimum of 150 subjects. Four sites are currently open for enrollment, but the first subject has not yet been enrolled. Assuming a 150 patient trial, preliminary results from VTI-210 are expected to be available in 2016.
Our final ongoing clinical trial is VTI-212. As previously disclosed, VTI-212 is being modified into a single-arm, open-label, multi-center Phase 2 clinical trial expected to enroll at least 40 subjects with fulminant hepatic failure or surgery induced liver failure, all of whom will be treated with the company’s ELAD System, plus standard-of-care. Treated subjects will be compared with case-controlled subjects treated with standard-of-care alone. Enrollment in VTI-212 is underway and we continue to expect results from VTI-212 in 2015 or 2016.
About Vital Therapies, Inc.
Vital Therapies, Inc. is a biotherapeutic company developing a cell-based therapy targeting treatment of acute liver failure. The company’s lead product-candidate, ELAD, is an extracorporeal bio-artificial liver therapy currently in Phase 3 clinical trials. Vital Therapies, Inc. is based in San Diego, California. Vital Therapies(R) and ELAD(R) are trademarks of Vital Therapies, Inc.
SOURCE: Vital Therapies
Post Views: 155
SAN DIEGO, CA, USA I July 9, 2014 I Vital Therapies, Inc. (VTL), a biotherapeutic company developing ELAD(R), a cell-based therapy targeting treatment of acute liver failure, is providing this update on the status of its clinical trials and the European Medical Agency’s (EMA) response to its request for advice through the Scientific Advice Working Party (SAWP) process.
As of today, 123 of a targeted 200 subjects have been enrolled in VTI-208, our randomized, controlled Phase 3 clinical trial in alcohol induced liver decompensation. Enrollment rates remain consistent with prior projections, and preliminary results are expected in the first half of 2015. Forty-eight clinical sites are now open in the USA, UK, Spain and Australia, and 37 sites have enrolled at least one subject.
Our second randomized, controlled, Phase 3 clinical trial, VTI-210, is studying the use of ELAD in subjects with acute alcoholic hepatitis (AAH) who have failed steroid therapy. As part of the process for preparing for a possible European Marketing Authorization Application (MAA) based primarily on VTI-210, we submitted a request earlier this year for SAWP advice on topics relating to the production and testing section of a future MAA, and on aspects of VTI-210 protocol design.
On June 30, 2014, we received detailed written responses from SAWP which provide constructive written guidance on both topics. We believe that the production and testing guidance is consistent with the company’s prior interactions with regulatory agencies and should pose no delays to existing timelines. The SAWP guidance also permitted the stratification of subjects into groups based on AAH diagnosis either by biopsy or by clinical grounds without biopsy. We plan to amend the protocol consistent with this guidance, and also to explore an event-driven design with a minimum of 150 subjects. Four sites are currently open for enrollment, but the first subject has not yet been enrolled. Assuming a 150 patient trial, preliminary results from VTI-210 are expected to be available in 2016.
Our final ongoing clinical trial is VTI-212. As previously disclosed, VTI-212 is being modified into a single-arm, open-label, multi-center Phase 2 clinical trial expected to enroll at least 40 subjects with fulminant hepatic failure or surgery induced liver failure, all of whom will be treated with the company’s ELAD System, plus standard-of-care. Treated subjects will be compared with case-controlled subjects treated with standard-of-care alone. Enrollment in VTI-212 is underway and we continue to expect results from VTI-212 in 2015 or 2016.
About Vital Therapies, Inc.
Vital Therapies, Inc. is a biotherapeutic company developing a cell-based therapy targeting treatment of acute liver failure. The company’s lead product-candidate, ELAD, is an extracorporeal bio-artificial liver therapy currently in Phase 3 clinical trials. Vital Therapies, Inc. is based in San Diego, California. Vital Therapies(R) and ELAD(R) are trademarks of Vital Therapies, Inc.
SOURCE: Vital Therapies
Post Views: 155
