Galena Biopharma to Present GALE-401 (Anagrelide Controlled Release) Phase 2 Clinical Trial Data at the European Hematology A...
May 22 2015 - 7:05AM
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company
developing and commercializing innovative, targeted oncology
therapeutics that address major medical needs across the full
spectrum of cancer care, today announced that data from the
Company's Phase 2 clinical trial of GALE-401, or Anagrelide
Controlled Release, will be presented at the upcoming European
Hematology Association 20th Congress in Vienna, Austria. Details of
the poster presentation are as follows:
Abstract #: |
P671 |
Title: |
Phase 2 Study of a Novel Controlled-Release
Formulation of Anagrelide (GALE-401) in Subjects with
Myeloproliferative Neoplasm (MPN)-Related Thrombocytosis |
Session Title: |
Myeloproliferative neoplasms - Clinical
2 |
Date: |
Saturday, June 13, 2015 |
Time: |
5:15 p.m. to 6:45 p.m. local time |
Location: |
Poster area (Hall C) |
About GALE-401 (Anagrelide Controlled
Release)
GALE-401 (Anagrelide Controlled Release) contains the active
ingredient anagrelide. The currently available immediate release
formulation (Agrylin® or anagrelide IR) is approved by the FDA for
the treatment of patients with thrombocythemia, secondary to
myeloproliferative disorders, to reduce the elevated platelet count
and the risk of thrombosis and to ameliorate associated symptoms
including thrombo-hemorrhagic events. Adverse events associated
with anagrelide IR, such as nausea, diarrhea, abdominal pain,
palpitations, tachycardia, and headache, may be dose and plasma
concentration dependent. Reducing the maximum plasma concentration
(Cmax) is expected to reduce side effects, but preserve efficacy.
GALE-401 is a reformulated, controlled release version of
anagrelide. In Phase 1 studies in healthy volunteers, GALE-401 was
shown to significantly reduce the Cmax while maintaining plasma
exposure to reduce platelet counts. Thus, GALE-401 may reduce
treatment-related adverse events while maintaining effective
therapeutic levels to decrease platelet production.
About Myeloproliferative Neoplasms
Myeloproliferative neoplasms (MPNs) are a closely related group
of hematological malignancies in which the bone marrow cells that
produce the body's blood cells develop and function abnormally. The
main MPNs are Polycythemia Vera (PV), Chronic Myelogenous Leukemia
(CML), Primary Myelofibrosis (PMF), Essential Thrombocythemia (ET),
and all of which are associated with high platelet counts. The MPNs
are progressive blood cancers that can strike anyone at any age,
and for which there is no known cure.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a biopharmaceutical
company developing and commercializing innovative, targeted
oncology therapeutics that address major medical needs across the
full spectrum of cancer care. Galena's development portfolio ranges
from mid- to late-stage clinical assets, including a robust
immunotherapy program led by NeuVax™ (nelipepimut-S) currently in
an international, Phase 3 clinical trial. The Company's commercial
drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz®
(ondansetron) Oral Soluble Film. Collectively, Galena's clinical
and commercial strategy focuses on identifying and advancing
therapeutic opportunities to improve cancer care, from direct
treatment of the disease to the reduction of its debilitating
side-effects. For more information, visit
www.galenabiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Such statements include, but are not limited to, statements
about the progress of the commercialization of Abstral® and
development of Galena's product candidates, including GALE-401,
patient enrollment in our clinical trials, as well as statements
about our expectations, plans and prospects. These forward-looking
statements are subject to a number of risks, uncertainties and
assumptions, including those identified under "Risk Factors" in
Galena's Annual Report on Form 10-K for the year ended December 31,
2014 and most recent Quarterly Reports on Form 10-Q filed with the
SEC. Actual results may differ materially from those contemplated
by these forward-looking statements. Galena does not undertake to
update any of these forward-looking statements to reflect a change
in its views or events or circumstances that occur after the date
of this press release.
Abstral and NeuVax are trademarks of Galena Biopharma, Inc. All
other trademarks are the property of their respective owners.
CONTACT: Remy Bernarda
SVP, Investor Relations & Corporate Communications
(503) 405-8258
rbernarda@galenabiopharma.com
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