Couldn't imagine $GALE standing up in front of the 57th American Society of Hematology (ASH) Annual Meeting and Exposition with bad data to report.
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Quote:Galena Biopharma to Present Final GALE-401 Phase 2 Clinical Data at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition
SAN RAMON, Calif., Nov. 6, 2015 (GLOBE NEWSWIRE) -- 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 (C max ) 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.
Remy Bernarda SVP, Investor Relations & Corporate Communications (925) 498-7709
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