Portola Pharmaceuticals Announces Presentation of Phase 3 APEX Study Results at International Society on Thrombosis and Haemo...
06 Avril 2016 - 2:00PM
Portola Pharmaceuticals (Nasdaq: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 WebcastPortola 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.
About the APEX StudyThe 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 PatientsAn
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.
About BetrixabanBetrixaban 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.
Investor Contact:
Ana Kapor
Portola Pharmaceuticals
ir@portola.com
Media Contact:
Julie Normart
W2O Group
jnormart@w2ogroup.com
Portola Pharmaceuticals (NASDAQ:PTLA)
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