PORTLAND, Ore., June 17, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced the completion of enrollment in the Company's Phase 2a clinical trial for GALE-301, or Folate Binding Protein (FBP) peptide immunotherapy. GALE-301 is administered to HLA-A2 positive patients in combination with granulocyte macrophage-colony stimulating factor (GM-CSF) as an adjuvant treatment to prevent recurrences in high-risk, ovarian and endometrial cancer patients rendered disease-free after completing standard of care therapy.
The Phase 2a is an open-label trial with two arms consisting of HLA-A2 positive patients treated with the FBP peptide plus GM-CSF and an observational control group of HLA-A2 negative patients. 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. The trial has completed enrollment of 45 patients. After an initial induction series of six vaccinations given once per month, patients will be administered booster inoculations at two subsequent 6-month intervals. The primary objectives of the trial are to measure the immune response, time to recurrence and overall survival between treatment arms.
"Completion of enrollment in the GALE-301 Phase 2a clinical trial ahead of schedule is an important milestone for Galena," said Mark J. Ahn, Ph.D., President and Chief Executive Officer. "We are now in the treatment and follow-up phase of the trial with the expectation of data readout in mid-2015. With promising results from the Phase 1 trial, we are encouraged to advance the GALE-301 program forward to prevent recurrence in women suffering from gynecological cancers."
As reported in a poster presentation at the American Society of Clinical Oncology (ASCO) 50th Annual Meeting earlier this month, 30 patients were enrolled in the GALE-301 Phase 1 trial. Of 14 control patients, 7 (50%) have recurred. Of 16 vaccinated patients, 4 (25%) have recurred after completing the primary vaccine series (PVS), 2 (12.5%) recurred prior to completing the PVS, and one patient discontinued treatment. Of note, no recurrences have been seen thus far in the optimal dose cohort of 1,000 mcg of peptide.
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 presenting 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 22,000 patients 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 that 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, the treatment options and successes 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 Portland, Oregon-based biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. 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 plans and the prospects for development of Galena's GALE-301 product candidate. 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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