Portola Pharmaceuticals Announces New APEX Study Sub-Analyses Data to be Presented at American Heart Association Scientific S...
07 Novembre 2016 - 2:00PM
Portola Pharmaceuticals Inc.® (Nasdaq:PTLA) today announced that
results of new sub-analyses of the Phase 3 APEX Study of
betrixaban, conducted by Dr. C. Michael Gibson and the PERFUSE
Study Group, will be presented in oral and poster sessions at the
upcoming American Heart Association (AHA) Scientific Sessions 2016,
which is taking place from November 12-16 in New Orleans.
Betrixaban, a U.S. Food and Drug Administration (FDA) Fast
Track-designated investigational drug, is an oral, once-daily
Factor Xa inhibitor anticoagulant in development for the prevention
of venous thromboembolism (VTE) in acute medically ill patients.
Portola submitted a New Drug Application to the FDA in October 2016
seeking approval to market betrixaban for extended-duration
prophylaxis of VTE in acute medically ill patients with risk
factors for VTE. Portola expects a response from the FDA within 60
days as to whether the NDA is complete and acceptable for
filing.
Following are details of the oral and poster presentations,
which will include additional data not available in the abstracts.
AHA will post the abstracts on Friday, November 11, at 4:00 p.m. ET
at http://www.abstractsonline.com/pp8/#!/4096.
Oral Presentations
- Abstract Title: Betrixaban reduces the burden of multiple
symptomatic venous thromboembolic events in the APEX trial
Abstract #: 640Presenting Author: Purva Jain, M.P.H.,
biostatistician, PERFUSE Study Group, Beth Israel Deaconess Medical
Center, BostonSession Title: Hemostasis, Thrombosis and
FibrinolysisPresentation Date and Time: Monday, November 14, 10:30
-10:35 a.m. CT Presentation Location: Science and Technology Hall,
Basic Science Theater
- Abstract Title: Extended duration betrixaban reduces the risk
of stroke vs standard dose enoxaparin among hospitalized medically
ill patients: An APEX substudy
Abstract #: 277Presenting Author: C. Michael Gibson, M.S., M.D.,
APEX Executive Committee Member and Steering Committee Chairman;
professor, Harvard Medical School; chairman, PERFUSE Study Group,
Beth Israel Deaconess Medical Center, BostonSession Title: Sol
Sherry Distinguished Lecture in ThrombosisPresentation Date and
Time: Monday, November 14, 3:15-3:25 p.m. CTPresentation Location:
Room 217
Poster Presentation
- Abstract Title: IMPROVEDD Score: Addition of D-dimer to the
IMPROVE score improves venous thromboembolism risk stratification:
An APEX trial substudy
Abstract #: T1201/1201Presenting Author: Gerald Chi, M.D.,
PERFUSE Study Group, Beth Israel Deaconess Medical Center,
BostonSession Title: Hemostasis, Thrombosis and
FibrinolysisPresentation Date and Time: Tuesday, November 15,
12:45-2:00 p.m. CTPresentation Location: Science and Technology
Hall, Basic Science Section
About the APEX StudyThe pivotal Phase 3 APEX
Study enrolled 7,513 patients at more than 450 clinical sites
worldwide and assessed the superiority of extended-duration
anticoagulation with oral betrixaban for 35-42 days compared with
standard-duration injectable enoxaparin for 10+4 days in preventing
VTE in high-risk acute medically ill patients. Full study results
were presented at the 62nd Annual International Society
on Thrombosis and Haemostasis (ISTH) Scientific and
Standardization Committee (SSC) Meeting in May 2016 and published
simultaneously online in The New England Journal of
Medicine.
About BetrixabanBetrixaban, an investigational
drug, 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 three programs, including betrixaban, an
oral, once-daily Factor Xa inhibitor; AndexXa™ (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.
Forward-looking StatementsStatements contained
in this press release regarding matters that are not historical
facts are "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results
may differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not
limited to, statements regarding development of our product
candidates, our regulatory applications and estimated timelines
associated therewith. Risks that contribute to the uncertain nature
of the forward-looking statements include: failure to obtain
regulatory approval for one or more of our product candidates, our
expectation that we will incur losses for the foreseeable future
and will need additional funds to finance our operations; the
results of our clinical trials related to the efficacy and safety
of our product candidates; our potential inability to manufacture
our product candidates on a commercial scale in a timely or
cost-efficient manner; the accuracy of our estimates regarding
expenses and capital requirements; regulatory developments in the
United States and foreign countries; our ability to obtain and
maintain intellectual property protection for our product
candidates; and our ability to retain key scientific or management
personnel. These and other risks and uncertainties are described
more fully in our most recent filings with the Securities and
Exchange Commission, including our most recent quarterly report on
Form 10-Q, which was filed on August 9, 2016. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. We undertake no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made.
Investor Contact:
Ana Kapor
Portola Pharmaceuticals
ir@portola.com
Media Contact:
Julie Normart
W2O Group
jnormart@w2ogroup.com
415.946.1087
Portola Pharmaceuticals (NASDAQ:PTLA)
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