|View printer-friendly version|
Portola Pharmaceuticals Announces Presentation of Phase 3 APEX Study Results at International Society on Thrombosis and Haemostasis (ISTH) SSC Meeting 2016 on May 27, 2016
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
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
Portola will host an investor webcast directly following the APEX data presentation at the SSC Meeting on
Portola announced topline data from the APEX Study, including results in Cohort 1, Cohort 2 and the overall population, on
About the APEX Study
The APEX (Acute Medically Ill VTE Prevention with Extended Duration Betrixaban) Study evaluated the superiority of extended-duration anticoagulation with oral betrixaban compared with standard of care anticoagulation with injectable enoxaparin for the prevention of VTE in acute medically ill patients.
The study was designed to assess the relative risk in the composite endpoint of ultrasound-detected (asymptomatic) proximal deep venous thrombosis (DVT), symptomatic DVT, non-fatal pulmonary embolism (PE) or VTE-related death in high-risk acute medically ill patients treated with oral betrixaban for 35-47 days versus standard of care preventive anticoagulation with injectable enoxaparin dosed for 10±4 days. APEX enrolled 7,513 patients at more than 450 clinical sites worldwide.
About VTE in Acute Medically Ill Patients
An estimated 20 million acute medically ill patients in the G7 countries are at risk of developing VTE either while in the hospital or following discharge. More than 1 million VTEs and 150,000 VTE-related deaths occur in acute medically ill patients each year in the G7 countries, despite the use of injectable enoxaparin in the hospital. Although more than half of VTE events occur after the patient is discharged from the hospital, no anticoagulant, including any of the marketed oral Factor Xa inhibitors, is approved for VTE prophylaxis in both the hospital setting and for the extended post-discharge period.
Betrixaban directly inhibits the activity of Factor Xa, an important validated target in the blood coagulation pathway, to prevent life-threatening thrombosis. Betrixaban has distinct properties that may allow it to demonstrate clinical benefit without the significant imbalance in the risk of major bleeding seen with other agents in the class. These include a 19-25-hour half-life for once-daily dosing; a low peak-to-trough drug concentration ratio that minimizes anticoagulant variability; low renal clearance; and no significant CYP3A4 metabolism, which may reduce the risk of drug-drug interactions.
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing its three programs using novel biomarker and genetic approaches that may increase the likelihood of clinical, regulatory and commercial success of its potentially life-saving therapies. These programs include betrixaban, an oral, once-daily Factor Xa inhibitor; andexanet alfa, a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola's partnered program is focused on developing selective Syk inhibitors for inflammatory conditions. For more information, visit www.portola.com and follow the Company on Twitter @Portola_Pharma.
Ana Kapor Portola Pharmaceuticalsir@portola.com Media Contact: Julie Normart W2O Groupjnormart@w2ogroup.com