Galena Biopharma Confirms Regulatory Pathway for GALE-401 (Anagrelide Controlled Release)

SAN RAMON, Calif., Dec. 28, 2016 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ: GALE), a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, today announced the Company has confirmed the regulatory pathway to advance GALE-401 (Anagrelide Controlled Release) into a pivotal, Phase 3 trial. After a productive meeting with the U.S. Food and Drug Administration (FDA), the Company has confirmed the development program and proposed clinical trial are appropriate for a New Drug Application (NDA) filing using the 505(b)(2) regulatory pathway. 

The Phase 3 clinical trial will enroll patients with essential thrombocythemia who have either failed or are intolerant to hydroxyurea, and will compare GALE-401 to the best available therapy (BAT) that will include a sizable subpopulation of patients treated with anagrelide immediate release. The Company expects to finalize the Phase 3 clinical trial protocol and initiate the trial in Q2, 2017.

“Confirmation of the 505(b)(2) regulatory pathway and preliminary agreement with the Agency on our Phase 3 clinical trial design is a significant step forward for our late stage program,” Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “Our controlled release version of anagrelide can offer a potential treatment option for patients with ET who have failed hydroxyurea. We remain on track to initiate the trial in the second quarter of 2017.”

About GALE-401 (Anagrelide Controlled Release)

GALE-401 is a controlled release formulation of anagrelide (Anagrelide CR) currently in clinical development for essential thrombocythemia.  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.  GALE-401 is a reformulated, controlled release version of anagrelide that reduces the maximum plasma concentration (Cmax) of the drug and is expected to reduce side effects, but preserve efficacy. A Phase 2 pilot study with GALE-401 has been completed.

About Essential Thrombocythemia

Essential Thrombocythemia (ET) is a chronic myeloproliferative neoplasm (MPN) characterized by the overproduction of platelets by megakaryocytes in the bone marrow. The U.S. prevalence of ET is between 135,000 and 175,000 with approximately seventy-five percent of patients receiving treatment.1 Common symptoms include headache, vision disturbances or migraines, dizziness or lightheadedness, coldness or blueness of fingers or toes, burning, redness, and pain in the hands and feet. Complications for patients with ET include blood clotting or bleeding or may be thrombotic in nature such as stroke, heart attack, or transient ischemic attack.

As with other MPNs, ET is a progressive blood cancer that can strike anyone at any age, and for which there is no known cure; and, there is no single treatment option that is appropriate or effective for all ET sufferers. While some ET patients may be asymptomatic and require no treatment, others may require various treatments and therapies based on the symptoms, their risk factors, and potential complications.  The treatment options are limited and are generally hydroxyurea prescribed first line, followed by other treatments including anagrelide immediate release, interferon, aspirin or other agents depending on the patient’s condition. Of these, only anagrelide IR is approved for treatment of ET patients.

1Mehta et al, (2014) Epidemiology of myeloproliferative neoplasms in the United States, Leukemia & Lymphoma, 55:3, 595-600, DOI: 10.3109/10428194.2013.813500

About Galena Biopharma

Galena Biopharma, Inc. is a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs. Galena’s pipeline consists of multiple mid-to-late-stage clinical assets led by its hematology asset, GALE-401, and novel cancer immunotherapy programs including NeuVax™ (nelipepimut-S) and GALE-301/GALE-302. 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 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, expected outcomes with regulatory agencies, and projected market opportunities for product candidates 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, 2015 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.

NeuVax is a trademark of Galena Biopharma, Inc. Agrylin is a trademark of Shire LLC.

Source: Galena Biopharma, Inc.

Remy Bernarda
SVP, Investor Relations & Corporate Communications
(925) 498-7709
[email protected]

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