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Galena Biopharma Presents GALE-301 (Folate Binding Protein Immunotherapy) Phase 2a Clinical Trial Data at the Society for Immunotherapy of Cancer (SITC) 29th Annual Meeting

  • Preliminary data shows a 31% recurrence rate in the vaccine group compared to 50% in the control group at a median follow up of 13 months, a 38% reduction in relative risk of recurrence
  • GALE-301 plus GM-CSF is well tolerated and elicits a strong in vivo immune response with primarily Grade 1 and Grade 2 toxicities
  • Top-line data to be presented mid-year 2015

PORTLAND, Ore., Nov. 7, 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 that data from the Company's Phase 1/2a trial of GALE-301, a Folate Binding Protein (FBP)-derived immunotherapy, will be presented today at the upcoming Society for Immunotherapy of Cancer (SITC) 29th Annual Meeting. The conference is taking place November 6-9, 2014 at the Gaylord National Hotel and Convention Center in National Harbor, Maryland. GALE-301 is a peptide immunotherapy given as an adjuvant treatment to prevent recurrences in high-risk, ovarian and endometrial cancer patients rendered disease-free after completing standard of care therapy.

Poster #87 (Abstract #52692) entitled, "Preliminary Results of the Phase 2a Trial of a Folate Binding Protein (FBP) Adjuvant Cancer Vaccine (E39+GM-CSF) in Ovarian and Endometrial Cancer Patients to Prevent Recurrence," will be presented during the General Poster Session today from 12:30 pm to 2:00 pm and 6:10 pm to 7:30 pm E.T.

"This preliminary data shows that GALE-301 is well tolerated, elicits a strong immune response, and appears to reduce the risk of recurrence in women with ovarian and endometrial cancer who were treated with our adjuvant therapy," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "These women are at a high risk for recurrence, as observed in the control group, with very poor outcomes and few treatment options in the adjuvant setting, making our preliminary findings extremely encouraging. We continue to follow these patients with top-line data expected mid-year 2015."

The Phase 2a is an open-label trial with two arms consisting of HLA-A2 positive patients treated with the FBP peptide in combination with granulocyte macrophage-colony stimulating factor (GM-CSF) and HLA-A2 negative patients followed prospectively as an untreated control group. The optimized dose of 1,000 mcg of peptide was determined from the Phase 1 trial and continued into the Phase 2a along with the addition of a booster regimen. After an initial induction series of six vaccinations given once per month, patients are administered booster inoculations at two subsequent 6-month intervals.

The Phase 1/2a trial enrolled 51 patients; 29 in the vaccine group and 22 in the control group.

The primary objectives of the trial are to measure the immune response, time to recurrence and overall survival between treatment arms. The preliminary results indicate GALE-301 is well tolerated and elicits a strong in vivo immune response. The majority of toxicities were Grade 1 and Grade 2: with maximum local skin reactions of 96% Grade 1, and 4% Grade 2. Maximum systemic toxicity was: 56.5% Grade 1, 26.1% Grade 2, and 4.3% Grade 3. Local reactions significantly increased from baseline with the first vaccination through the six-month primary vaccination series, demonstrating a strong and sustained immune response. After a median follow-up of 13 months, there have been 11/22 (50%) recurrences in the control group compared to 9/29 (31%) recurrences in the vaccine group, a 38% reduction in relative risk of recurrence. The study was not powered for efficacy but rather, a clinical proof of concept study. GALE-301 generates a long lasting immune response, which generates tumor lysing CD8 T cells, bypassing the need for active receptor or ligand binding to generate efficacy.

About GALE-301 (Folate Binding Protein (FBP) vaccine)

GALE-301 (Folate Binding Protein (FBP)) cancer immunotherapy is an investigational new drug targeting FBP, a well-validated therapeutic target, which is highly over-expressed in breast, ovarian and endometrial cancers. FBP is the source of immunogenic peptides that can stimulate cytotoxic T lymphocytes (CTLs) to recognize and destroy FBP-expressing cancer cells. GALE-301 consists of the FBP peptide(s) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF). GALE-301 has completed enrollment in a Phase 2a trial in two gynecological cancers: ovarian cancer and endometrial adenocarcinomas.

About Ovarian/Endometrial Cancers

Ovarian cancer occurs in more than 40,000 women per year in the U.S. and is the most lethal gynecologic cancer. Despite the incidence of ovarian cancer being only approximately 20% of that of breast cancer, the number of patients who die from ovarian cancer is nearly 50% of that of breast cancer. Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease. These patients have their tumors routinely surgically debulked to minimal residual disease, and then are treated with platinum- and/or taxane-based chemotherapy. While most patients respond to this treatment regimen and become clinically free-of-disease, the majority of these patients will relapse, and once the disease recurs, treatment options are limited and successes of subsequent interventions drop dramatically.

Endometrial cancer is the most common gynecologic cancer and occurs in more than 46,000 women with more than 8,000 deaths in the U.S. annually. There are two basic types of endometrial cancer: endometrioid and papillary serous. The latter has a much more aggressive clinical course and the majority of these patients will die of this form of the disease.

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.

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 commercialization of Abstral® and development of Galena's product candidates, including GALE-301, patient enrollment in our clinical trials, as well as statements about our expectations, plans and prospects. 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.

CONTACT: Remy Bernarda VP, Marketing & Communications (503) 405-8258 rbernarda@galenabiopharma.com

Source:Galena Biopharma