Galena Biopharma to Provide Corporate and Clinical

SAN RAMON, Calif., Jan. 05, 2017 (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 provided a corporate and clinical outlook for 2017 and announced that Mark W. Schwartz, Ph.D., President and Chief Executive Officer will give a company presentation at the Biotech Showcase 2017. The presentation will take place on Wednesday, January 11, 2017 at 10:30 a.m. PT at the Hilton San Francisco Union Square. The presentation will be webcast and available on the Investors section of the Company's website at http://investors.galenabiopharma.com/events.cfm .

“2017 looks to be promising for Galena Biopharma as we prepare to initiate our Phase 3 clinical trial in patients with essential thrombocythemia (ET) with GALE-401, our controlled release version of anagrelide,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “After a productive meeting with the U.S. Food and Drug Administration (FDA) last month, we were pleased to confirm that the GALE-401 development program is appropriate for a New Drug Application (NDA) filing using the 505(b)(2) regulatory pathway in patients who are intolerant to or failed to achieve an optimal response with hydroxyurea. In the U.S., ET has a prevalence of approximately 150,000 people and we estimate up to 25% of those patients who receive initial treatment with hydroxyurea may be candidates for the GALE-401 trial.  We expect to finalize the details of the Phase 3 clinical trial protocol including the trial size, endpoints, and dosing this quarter and initiate the trial in the second quarter of 2017.”

Dr. Schwartz continued, “We were also excited to announce last month that the Phase 2 clinical trial with NeuVax™ (nelipepimut-S) in Ductal Carcinoma in Situ (DCIS) resumed enrollment. In 2017, we expect enrollment to be completed in both of our NeuVax and trastuzumab combination trials. These investigator-sponsored trials (ISTs) are relatively low cost and allow us to leverage our resources to validate NeuVax as a potential treatment option whether as a stand-alone therapy or in combination with other agents. We believe there is substantial interest in the potential efficacy of NeuVax in a number of breast cancer indications and other malignancies such as gastric cancer, and ISTs such as these allow us to expand the utility of the agent.  Similarly, with our folate binding protein (FBP) programs, GALE-301 and GALE-302, our investigators provided a wealth of data in 2016 at various medical conferences including a November publication in Oncotarget on the GALE-301 interim analysis. These data on dosing and treatment schedules are extremely valuable as they highlight the potential utility of the vaccine in different cancer indications.”

Dr. Schwartz concluded, “As 2017 begins, we have a well defined pipeline and continue to be a late-stage company with a planned, Phase 3 clinical trial initiation with GALE-401 next quarter.  We are pleased with the advancement of NeuVax in both the combination and DCIS trials and look forward to reaching meaningful enrollment milestones in these trials this year.  The dedication of our shareholders, our employees, study sites, and patients will help us reach our ultimate goal of making a difference in the treatment of hematologic conditions and preventing recurrence in cancer patients.” 

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 (C _max ) of the drug and is expected to reduce side effects, but preserve efficacy.

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.

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

About NeuVax™ (nelipepimut-S)

NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting.   It is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading.   In clinical studies, NeuVax is combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF).

NeuVax is currently in two breast cancer studies in combination with trastuzumab (Herceptin®; Genentech/Roche): a Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial in high risk, node positive or negative HER2 IHC 3+ patients (clinicaltrials.gov identifier: NCT02297698).  A Phase 2 clinical trial is also ongoing with NeuVax in patients with ductal carcinoma in situ (DCIS) (clinicaltrials.gov identifier: NCT02636582), and a Phase 2 trial is planned in patients with gastric cancer.

About GALE-301 and GALE-302

GALE-301 and GALE-302 are cancer immunotherapies that consist of a peptide derived from Folate Binding Protein (FBP) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the prevention of cancer recurrence in the adjuvant setting.  GALE-301 is the E39 peptide, while GALE-302 is an attenuated version of this peptide, known as E39’.  FBP is a well-validated therapeutic target that is highly over-expressed in ovarian, endometrial and breast cancers, and is the source of immunogenic peptides that can stimulate cytotoxic T lymphocytes (CTLs) to recognize and destroy FBP-expressing cancer cells. Two trials are ongoing with FBP peptides: the GALE-301 Phase 2a portion of the Phase 1/2a clinical trial is ongoing in ovarian and endometrial adenocarcinomas (ClinicalTrials.gov Identifier: NCT01580696); the GALE-301 plus GALE-302 Phase 1b clinical trial is ongoing in breast and ovarian cancers (ClinicalTrials.gov Identifier: NCT02019524).

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, 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.

Source: Galena Biopharma, Inc.

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