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Galena Biopharma Presents GALE-401 Combined Safety Data at the European Hematology Association 21st Congress

SAN RAMON, Calif., June 13, 2016 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced that combined safety data from the Company’s GALE-401 clinical trials were presented at the European Hematology Association 21st Congress. GALE-401 is Galena’s controlled release (CR) version of anagrelide for the treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce elevated platelet counts in patients suffering from myeloproliferative neoplasms (MPNs).

A total of six trials have been run with GALE-401, five Phase 1 trials in healthy volunteers (N=98), and one Phase 2 single arm, open label pilot study in MPN patients (N=18). The poster, entitled, “Anagrelide Controlled Release (GALE-401) Safety Profile Consistently Well Tolerated in Myeloproliferative Neoplasms Patients and Healthy Volunteers” was designed to characterize the safety profile of GALE-401 in all subjects treated to date. The results demonstrated that GALE-401 is well tolerated in MPN patients as well as in healthy volunteers. In the Phase 2 study, fewer moderate to severe (Grade 3/4) adverse events (AEs) and fewer AEs per patient (2.3 vs. 3.3) were observed with GALE-401 compared to what has been reported previously with the immediate release (IR) formulation.1 Additionally, for a small subset of subjects treated in the Phase 2 study who were intolerant to anagrelide IR (n=5), GALE-401 appears to offer a longer duration on therapy compared to previous administration of anagrelide IR. Therefore, a randomized trial comparing GALE-401 vs. anagrelide IR in anagrelide naïve subjects, alternatively or together with a trial evaluating anagrelide IR intolerant subjects is warranted.

“The clinical and pharmacokinetic profile of GALE-401 has shown that by reducing the maximum plasma concentration (Cmax) of anagrelide with our controlled release version, GALE-401 seems to confer an improved overall safety profile and potentially offers an improved tolerability compared to the approved product,” said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. “Overall, in our Phase 2 study, we observed predominantly mild to moderate toxicities that did not reveal any unexpected AEs, and we are encouraged by the results as it relates to patients who were previously intolerant to anagrelide IR who were able to continue their treatment with GALE-401 for a meaningful longer duration. Given this data, we plan to meet with the FDA later this year to discuss the next stages of development for the asset.”

In the healthy volunteer studies, single and multiple doses of GALE-401 were safe and well tolerated and there were no clinically relevant changes in vital signs, electrocardiograms, and safety laboratory parameters other than a reduction in platelet counts. The most frequent treatment emergent adverse events reported included headache, pain in extremities or back, palpitations and gastrointestinal disturbances. In the Phase 2 MPN trial, patients treated with GALE-401 exhibited fewer of the more common adverse events associated with anagrelide IR (cardiac; general; gastrointestinal; respiratory, thoracic, and mediastinal; skin and subcutaneous tissue; nervous system). Some of the less common AEs of anagrelide IR were comparatively more frequent for GALE-401 (vascular; hepatobiliary; blood and lymphatic).

The poster presentation from the conference can be found on Galena’s website here.

1Source: Verstovsek S, et al. ASH Poster Presentation 2015; Agrylin® Prescription Information. Additional detail on the trial can be found in the abstract the on the conference website here

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 has been completed.

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. is a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs. Galena’s development portfolio is focused primarily on addressing the rapidly growing patient populations of cancer survivors by harnessing the power of the immune system to prevent cancer recurrence. The Company’s pipeline consists of multiple mid- to late-stage clinical assets, including novel cancer immunotherapy programs led by NeuVax™ (nelipepimut-S) and GALE-301. NeuVax is currently in a pivotal, Phase 3 breast cancer clinical trial with several concurrent Phase 2 trials ongoing both as a single agent and in combination with other therapies. GALE-301 is in a Phase 2a clinical trial in ovarian and endometrial cancers and in a Phase 1b given sequentially with 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.

Contact: Remy Bernarda SVP, Investor Relations & Corporate Communications (925) 498-7709 ir@galenabiopharma.com

Source:Galena Biopharma, Inc.