Portola Pharmaceuticals PTLA today announced that data from its Phase 3 APEX Study of betrixaban will be presented at the International Society on Thrombosis and Haemostasis (ISTH) 62nd Annual SSC (Scientific and Standardization Committee) Meeting, which is taking place from May 25-28 in Montpellier, France. Portola is developing betrixaban, an oral Factor Xa inhibitor anticoagulant, for the prevention of venous thromboembolism (VTE), or blood clots, in acute medically ill patients.
APEX Study Oral Presentation Details
Presentation Title: Results of the APEX Trial
Presenting Author: C. Michael Gibson, M.S., M.D., professor of medicine, Harvard Medical School, PERFUSE Study Group, Beth Israel Deaconess Medical Center
Session Title: Control of Anticoagulation, Part 1
Presentation Date and Time: Friday, May 27, 2:30 p.m. CET / 8:30 am ET
Location: Einstein Room, Le Corum Conference Centre.
Presentation will include the following data:
Cohort 1 – Primary efficacy and primary safety analysis
Cohort 2 – Primary efficacy and primary safety analysis
Overall study population – Primary efficacy and primary safety analysis
Cohort 1 – First pre-specified secondary endpoint, symptomatic events
Cohort 2 – First pre-specified secondary endpoint, symptomatic events
Overall study population – First pre-specified secondary endpoint, symptomatic events
Pre-specified sensitivity analysis – Cohort 1 efficacy when D-dimer is measured by central lab
Pre-specified analyses of net clinical benefit – Cohort 1, Cohort 2 and the overall study population
Pre-specified sensitivity analyses of efficacy and safety outcomes in subgroups, including by hospital admission diagnosis
Investor Webcast
Portola will host an investor webcast directly following the APEX data presentation at the SSC Meeting on May 27, during which members of its senior management team and Dr. Gibson and Dr. Alexander (Ander) T. Cohen, MBBS, M.Sc., M.D., co-principal investigator of APEX and honorary consultant vascular physician at King's College London, will present and discuss the APEX Study data. Portola will announce webcast details in mid-May.
Portola announced topline data from the APEX Study, including results in Cohort 1, Cohort 2 and the overall population, on March 24, 2016.
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