GALENA Biopharma to Present GALE-401 (Anagrelide Controlled Release) Phase 2 Clinical Trial Data at the European Hematology Association 20th Congress
May 22, 2015 07:05:00 (ET)
Galena Biopharma to Present GALE-401 (Anagrelide Controlled Release) Phase 2 Clinical Trial Data at the European Hematology Association 20th Congress
PORTLAND, Ore., May 22, 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 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 20(th) 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(R) 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. In Phase 1 studies in healthy volunteers, GALE-401 was shown to significantly reduce the C(max) 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.
