– ON TRACK FOR RELEASE OF TOPLINE DATA IN THE SECOND QUARTER OF 2015 –
– 200 PATIENTS ENROLLED –
SAN DIEGO, CA, USA I January 30, 2015 I Vital Therapies, Inc. (VTL), a biotherapeutic company developing ELAD(R), a human cell-based therapy targeting treatment of acute liver failure, today announced achievement of the 200 subject enrollment target in VTI-208, the Company’s randomized, controlled, open-label Phase 3 clinical trial in 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,” said Terry Winters, Ph.D., the Company’s Chief Executive Officer and Co-Chairman. “We are grateful to all of our investigators and their staffs who worked diligently to enroll and care for the targeted subjects. 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.”
VTI-208 is a randomized, controlled, open-label Phase 3 clinical trial in alcohol induced liver decompensation. The 200th subject was enrolled on January 28, 2015. A small number of additional subjects already in the active screening process may be enrolled over the next few days. The trial’s primary endpoint is overall survival up to at least study day 91.
VTI-210, the Company’s second Phase 3 trial, is a randomized, controlled, open-label study evaluating the ELAD system in severe AAH patients who have failed standard therapy. This trial targets enrollment of a minimum of 150 subjects with a primary endpoint of overall survival up to at least study day 91. The Company expects topline data from this trial in 2016.
Separately, the Company will be participating in the NASDAQ Closing Bell Ceremony taking place at 4 PM ET on Tuesday, February 24, 2015 at the NASDAQ MarketSite Broadcast Studio, 4 Times Square, New York, NY.
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, the ELAD System, 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: 228
– ON TRACK FOR RELEASE OF TOPLINE DATA IN THE SECOND QUARTER OF 2015 –
– 200 PATIENTS ENROLLED –
SAN DIEGO, CA, USA I January 30, 2015 I Vital Therapies, Inc. (VTL), a biotherapeutic company developing ELAD(R), a human cell-based therapy targeting treatment of acute liver failure, today announced achievement of the 200 subject enrollment target in VTI-208, the Company’s randomized, controlled, open-label Phase 3 clinical trial in 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,” said Terry Winters, Ph.D., the Company’s Chief Executive Officer and Co-Chairman. “We are grateful to all of our investigators and their staffs who worked diligently to enroll and care for the targeted subjects. 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.”
VTI-208 is a randomized, controlled, open-label Phase 3 clinical trial in alcohol induced liver decompensation. The 200th subject was enrolled on January 28, 2015. A small number of additional subjects already in the active screening process may be enrolled over the next few days. The trial’s primary endpoint is overall survival up to at least study day 91.
VTI-210, the Company’s second Phase 3 trial, is a randomized, controlled, open-label study evaluating the ELAD system in severe AAH patients who have failed standard therapy. This trial targets enrollment of a minimum of 150 subjects with a primary endpoint of overall survival up to at least study day 91. The Company expects topline data from this trial in 2016.
Separately, the Company will be participating in the NASDAQ Closing Bell Ceremony taking place at 4 PM ET on Tuesday, February 24, 2015 at the NASDAQ MarketSite Broadcast Studio, 4 Times Square, New York, NY.
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, the ELAD System, 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: 228
