IRX-2 has been evaluated in 2 previous clinical studies:
IRX-2 has been adequately tolerated to date with good treatment compliance throughout its clinical program.
In the most recent Phase 2 study, 8 serious adverse events (SAEs) were reported in 7 patients.
Overall, the pattern of SAEs is consistent with that expected in this patient population and does not suggest that the IRX-2 regimen is associated with the occurrence of any unique SAEs.1,2
During clinical studies, changes that may suggest efficacy have been observed in the key cell counts, lymph node changes, infiltration of lymphocytes into the tumor, some regression, delayed recurrence, and improved survival.1,2 In the Phase 2a study, the occurrence of an immunologically mediated antitumor effect was suggested by2,3
Increased lymphocyte infiltration in patients with head and neck cancer treated with the IRX-2 immunotherapy regimen. Cancer Immunol Immunother. 2012;61:771-782.
A phase 1 safety study of an IRX-2 regimen in patients with squamous cell carcinoma of the head and neck. Am J Clin Oncol. 2011;34:173-178.
A short course of neoadjuvant
IRX-2 induces changes in peripheral blood lymphocyte subsets of patients with head and neck squamous cell carcinoma. Cancer Immunol Immunother. 2012;61:783-788.
Novel neoadjuvant immunotherapy regimen safety and survival in head and neck squamous cell cancer. Head Neck.