PORTLAND, Ore., Sept. 9, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced the first patient has been dosed in the GALE-401, or Anagrelide Controlled Release (CR), Phase 2 Clinical Trial. The Phase 2 study will treat patients with elevated platelet counts in myeloproliferative neoplasms (MPNs) including essential thrombocythemia (ET). Based on discussions with the U.S. Food and Drug Administration (FDA) and pending a successful development program, Galena would pursue approval via the 505(b)(2) regulatory pathway.
The Phase 2 trial is an open-label, single-arm, multicenter study of GALE-401 in 20 patients with MPN-related thrombocytosis. The goals of the study are to confirm the platelet-lowering activity of GALE-401 in patients with MPNs, to assess safety and tolerability, and to measure blood levels of the drug. The primary efficacy endpoint will be the proportion of subjects who achieve a complete or partial platelet response for at least four weeks during the first six months of treatment.
"Moving GALE-401 into the clinic is an important advancement in the treatment of MPN diseases, as well as for Galena's overall product pipeline," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "The initiation of this Phase 2 trial officially signals Galena's expansion into hematology following our acquisition of the compound earlier this year. With GALE-401, we hope to offer an alternative treatment option for patients suffering from high platelet counts resulting from MPN diseases. I am proud of our clinical development team's effort to advance this program and we look forward to top line data from the study in 2015."
MPNs encompass a family of diseases including essential thrombocythemia, polycythemia vera, primary myelofibrosis, and chronic myelogenous leukemia. The active ingredient immediate release version of anagrelide has been shown to reduce excessive platelet counts and has been approved by the FDA for treating high platelet counts in patients with MPNs. Anagrelide CR is Galena's new formulation of anagrelide that releases the active ingredient more slowly over time than currently marketed versions of this drug, and is therefore absorbed more slowly into the bloodstream. This slower release of drug could help to reduce adverse events that might be caused by high blood concentrations when the drug is absorbed rapidly, as it is with currently marketed products.
"While current treatment options for high platelet counts are effective, they sometimes cause significant side-effects that may prevent patients from taking an adequate dose of their medications. I look forward to working with anagrelide CR to explore this formulation to slowly release the drug into the patient's system and potentially provide better outcomes," added Srdan Verstovsek, M.D., Ph.D., Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, and principal investigator for the Phase 2 trial.
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 myeloproliferative neoplasms are Polycythemia Vera (PV), Essential Thrombocythemia (ET), Primary Myelofibrosis (PMF), and Chronic Myelogenous Leukemia (CML), 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 GALE-401 (Anagrelide CR)
GALE-401 (Anagrelide CR) contains the active ingredient anagrelide. The currently available immediate release formulation (anagrelide IR) is approved by the FDA for the treatment of high platelet counts in patients with Myeloproliferative Neoplasms (MPNs), including Polycythemia Vera (PV), Chronic Myelogenous Leukemia (CML), Primary Myelofibrosis (PMF), and Essential Thrombocythemia (ET). 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 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.
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 development of Galena's GALE-401 product candidate, including patient enrollment in our clinical trial, as well as statements about our expectations, plans and prospects for our development and commercial products. 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, 2013 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.
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