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galena biopharma inc (GALE) Details

Galena Biopharma, Inc., a biopharmaceutical company, focuses on developing and commercializing oncology treatments that address major unmet medical needs to advance cancer care. Its commercial product includes Abstral, a sublingual tablet, which is used as treatment option for breakthrough cancer pain in patients. The company’s lead product candidate comprise NeuVax (nelipepimut-S or E75), which has completed Phase III clinical trials for preventing the recurrence of breast cancer; and Phase IIb clinical trials in combination with Herceptin for the treatment of breast cancer. It also develops GALE-301 or Folate Binding Protein (FBP), a therapeutic target that has completed Phase II clinical trials for the treatment of ovarian and endometrial cancers; and GALE-401 (Anagrelide CR), which has completed Phase I studies for the treatment of essential thrombocythemia. Galena Biopharma, Inc. has strategic partnership with Dr. Reddy's Laboratories Ltd. The company was formerly known as RXi Pharmaceuticals Corporation and changed its name to Galena Biopharma, Inc. in September 2011. Galena Biopharma, Inc. was founded in 2003 and is based in Lake Portland, Oregon.

60 Employees
Last Reported Date: 03/17/14
Founded in 2003

galena biopharma inc (GALE) Top Compensated Officers

Chief Executive Officer, President, Director ...
Total Annual Compensation: $737.0K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $236.0K
Chief Operating Officer and Executive Vice Pr...
Total Annual Compensation: $490.0K
Chief Medical Officer and Executive Vice Pres...
Total Annual Compensation: $127.3K
Compensation as of Fiscal Year 2013.

galena biopharma inc (GALE) Key Developments

Galena Biopharma Announces Data from Phase I Cancer Vaccine Trial

Galena Biopharma announced encouraging data from a Phase I study with GALE-301, or folate binding protein, in patients with ovarian and endometrial cancer. Folate Receptor Alpha (FRÂÃ) (also known as FBP) is an immunogenic protein that is over-expressed in breast, lung, endometrial and ovarian cancers. FR¨¢ expression in malignant cells is 20-80 fold higher compared to normal cells. Galena conducted a Phase I dose escalation clinical trial with E39, an HLA-A2 positive, FR¨¢ peptide combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF). The vaccine is administered in the adjuvant setting to prevent recurrences in high-risk endometrial and ovarian cancer patients rendered clinically disease-free after standard-of-care therapy. The current analysis compared in vivo immunologic responses (IR) and disease features between vaccinated non-recurrent (vNR) and vaccinated recurrent (vR) patients. Overall, 30 patients were enrolled in the Phase I 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 withdrew. Of note, no recurrences have been seen in the optimal dose cohort of 1000 mcg E39. The vR patients displayed lower mean delayed type hypersensitivity (DTH) reactions as well as lower local reactions at every measured time point. In the Phase I study, HLA-A2 positive patients were enrolled into the vaccine group and received intradermal inoculations of E39 + 250 mcg GM-CSF once a month for six months (the PVS) following assignment into a dose cohort: 100mcg, 500mcg, or 1000mcg of E39. In vivo IR was assessed by both local reaction (LR) after each inoculation and DTH reaction measured pre-vaccination and post-PVS (DTH2). Comparison between vNR and vR patients demonstrates recurrences are likely related to trends in both disease features (age but not stage) as well as diminished response to the vaccine as seen by LR and DTH. As decreased vaccine response may be related to more aggressive disease, the most viable way to address this observation is to vaccinate in earlier stage disease. The ongoing Phase IIa trial is attempting to establish a preliminary efficacy signal, as well as evaluate a longer-term booster regimen.

Galena Biopharma, Inc. Presents at BIO International Convention, Jun-25-2014 03:15 PM

Galena Biopharma, Inc. Presents at BIO International Convention, Jun-25-2014 03:15 PM. Venue: San Diego Convention Center, San Diego, California, United States.

Galena Biopharma, Inc. Completes Enrollment in Gale-301 Phase 2A Clinical Trial in Ovarian and Endometrial Cancers

Galena Biopharma, Inc. 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. 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. 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.


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