Galena Biopharma to Present Final GALE-401 Phase 2 Clinical Data at the 57th American Society of Hematology (ASH) Annual Meet...
November 06 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 the final data from the
Company's GALE-401 (anagrelide controlled release) Phase 2
proof-of-concept clinical trial will be presented at the upcoming
57th American Society of Hematology (ASH) Annual Meeting and
Exposition in Orlando, FL. Details of the poster presentation are
as follows:
Poster #: |
4074 - the abstract can be found on the
conference website here |
Title: |
Final results of anagrelide
controlled-release (GALE-401) safety, efficacy and pharmacokinetics
in subjects with myeloproliferative neoplasms (MPN)-related
thrombocytosis |
Session Title: |
634, Myeloproliferative Syndromes: Clinical:
Poster III
|
Date: |
Monday, December 7, 2015 |
Time: |
6:00 PM to 8:00 PM Eastern time |
Location: |
Orange County Convention Center, Hall A,
Level 2 |
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. A Phase 2 pilot study with
GALE-401 is ongoing.
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), and essential thrombocythemia
(ET), 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 our
commercial products and development of Galena's product candidates,
including GALE-401, patient enrollment in our clinical trials, as
well as other statements related to the progress and timing of our
development activities, present or future licensing, collaborative
or financing arrangements or that otherwise relate to future
periods. 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
(925) 498-7709
rbernarda@galenabiopharma.com
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