Galena Biopharma (NASDAQ:GALE)’s GALE-301 Enrolls First Patient
Galena Biopharma (NASDAQ:GALE), a biopharmaceutical company developing oncology treatments, has announced that the Phase 2 clinical trial for the company’s GALE-301 (Folate Binding Protein (FBP) vaccine) has enrolled the first patient.
The folate receptor alpha-derived, peptide-based cancer immunotherapy ‘GALE-301’ aims to “prevent recurrences in high-risk, endometrial and ovarian cancer patients rendered disease-free after completing standard of care therapy.”
The immunotherapy is administered for HLA-A2 positive patients in combination with GM-CSF (granulocyte macrophage-colony stimulating factor) as an adjuvant treatment.
The Phase-2 trial will see use of the optimized dose, along with the implementation of a booster regimen. In this trial, HLA-A2 positive patients will be treated with the FBP peptide plus adjuvant versus active control. After an initial induction series of six vaccinations given once per month, patients will be boosted twice at 6-month intervals. The primary objective of the Phase 2 trial is to measure immune response, with secondary outcomes of recurrence.
According to the company, the Phase 1 trial of GALE-301 was a success and the initial study data showed that the GALE-301 was well tolerated and evoked a FBP specific immunological response. The primary outcome of the Phase 1 trial was to determine safety and the optimal dose.
Galena Biopharma President and CEO Mark J. Ahn said, “With GALE-301 progressing into its Phase 2 trial, we continue to demonstrate progress of our innovative cancer immunotherapy pipeline. 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 company said it is encouraged by the initial results of GALE-301 Phase 1 trial, which showed promising immune responses in high risk gynaecological cancers.
Galena’s FBP vaccine is currently in a Phase 1/2 trial in two gynaecological cancers — ovarian and endometrial adenocarcinomas. Ovarian cancer occurs in more than 22,000 patients a year in the United States, while endometrial cancer is the most common gynaecologic cancer and occurs in over 46,000 women, with over 8,000 deaths annually, in the U.S. alone.