Studies primary investigator George Peoples said new treatment options are needed to address unmet medical needs for breast cancer patients with HER2 low-to-intermediate expression or IHC 1+/2+ disease.
"I’m very pleased with the overall conduct of the Phase 1/2 adjuvant trials which have demonstrated the safety and efficacy of NeuVax to prevent recurrence, and want to thank the physicians and patients who participated in the studies," Peoples added.
The SN-33 and SN-34 trials have enrolled patients who were rendered disease-free after completion of standard of care multi-modality therapy for 60 months.
The 60-month landmark analysis of the SN-33 trial has demonstrated that breast cancer recurrence was reduced for patients treated with NeuVax.
Ongoing phase 3 PRESENT trial is based on the SN-33 trial conducted in node positive patients.
Galena Biopharma president and chief executive officer Mark Ahn said 94.4% of the phase 3 target patient population of HER2 low-to-intermediate IHC 1+/2+ patients remained disease-free.
”Based on these results, we continue to believe NeuVax may be a potential treatment option to prevent breast cancer recurrence for those women who currently have no HER2-directed treatment options," Ahn added.