US-based biopharmaceutical firm Galena Biopharma has reported positive final results from the Phase I/IIa clinical trial of GALE-301 (E39) to prevent recurrence of ovarian and endometrial cancer.
GALE-301 is a cancer immunotherapy that contains a peptide derived from folate binding protein (FBP) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF).
The results from the trial demonstrated that GALE-301 is well tolerated and achieved a statistically significant disease free survival in a small number of patients treated with the optimal dose.
The investigator-sponsored prospective Phase I/IIa trial evaluated the ability of GALE-301 to prevent recurrence in disease-free patients at high risk for recurrence after standard of care treatments.
Galena Biopharma executive vice-president and chief medical officer Bijan Nejadnik said: “The data also showed a meaningful correlation between delayed type hypersensitivity reactions and clinical outcomes, indicating that the vaccine is able to generate an immune response.
"The results of the trial also reiterate our focus on treating patients with primary disease after their initial standard of care treatment where we believe GALE-301 may provide the most benefit."
The patients with primary or recurrent endometrial, ovarian, fallopian tube or peritoneal cancer were enrolled.
The Phase I part was a dose-escalation trial, while the Phase IIa part compared expanded dose cohorts in a total of 51 patients, of which forty patients were enrolled after standard of care treatment of primary disease and 11 patients after the recurrent disease treatment.
The trial's final endpoint was disease-free survival (DFS) after two years.
Image: CT showing ovarian cancer. Photo: courtesy of James Heilman/Wikipedia.
