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Galena Biopharma, Inc. (GALE) Enrolls First Patient In Phase 2 Trial For Endometrial, Ovarian Cancer Vaccine

Jan. 07, 2014 2:48 PM ETSLS
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Galena Biopharma, a biopharmaceutical company developing oncology treatments to advance cancer care, today reports that it has enrolled the first patient in the phase 2 trial for GALE-301, the company's folate binding protein (FBP) vaccine. GALE-301 will be administered in combination with granulocyte macrophage-colony stimulating factor (GM-CSF) as an adjuvant treatment to prevent recurrences in high-risk, endometrial and ovarian cancer patients that have been rendered disease-free after completing standard of care therapy.

The phase 2 is an open-label trial with two arms consisting of HLA-A2 positive patients treated with the FBP peptide plus adjuvant versus active control. Following the initial induction series of six vaccinations given once per month, patients will be boosted twice at six-month intervals.

The primary endpoint of this phase 2 trial is to measure immune response, with secondary outcomes of recurrence. The company's optimism for the outcome of the phase 2 trial is largely due to positive phase 1 results.

"With GALE-301 progressing into its phase 2 trial, we continue to demonstrate progress of our innovative cancer immunotherapy pipeline," Mark J. Ahn, Ph.D., GALE's president and CEO, stated in the news release. "Once recurrent, ovarian and endometrial cancers are two of the deadliest malignancies, therefore preventing metastatic disease is critical. We are encouraged by the promising early results of GALE-301 in addressing this critical unmet medical need."

The early results referenced by Dr. Ahn are the initial results from Galena's phase 1 trial, in which the optimal dose was determined. Furthermore, data showed that GALE-301 was well-tolerated and evoked a FBP specific immunological response. After a median follow-up of six months from completion of the vaccine series, there were two recurrences (13.3%) in the vaccine group vs. four recurrences (25%) in the control group, though the company notes that the trial was not powered for any efficacy measurements.

For more information, visit galenabiopharma.com

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