Trial Information

A Phase 2, Open-label Trial of the Safety and Biological Effect of Subcutaneous IRX-2 (With Cyclophosphamide, Indomethacin, and Zinc) in Patients With Resectable Cancer of the Head and Neck

IRX-2 is a biologic product that contains multiple cytokines produced under pharmaceutical
standards from phytohemagglutinin (PHA) stimulated mononuclear cells obtained from normal
healthy donors. The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an
initial low dose of cyclophosphamide and a 3-week course of indomethacin and zinc
supplementation.

The present study is based in large part on observations made during an exploratory Phase
1-2 study of the safety and efficacy of the IRX-2 regimen performed at the Instituto
Nacional de Cancerologia (INCAN), Mexico's National Cancer Institute. Patients with head
and neck (HN) squamous cell carcinoma (SCC) were treated with the IRX-2 regimen, some as
neoadjuvant therapy prior to surgery and some for advanced disease. Three different doses
and dose schedules were studied. Evaluation of clinical safety included regular clinical
and laboratory evaluations. In the patients treated before surgery, evaluation of tumor
response was undertaken by comparison of tumor size before and after the IRX-2 regimen.
This study provided preliminary evidence of the safety and possible efficacy of IRX-2 in the
pre-surgical, neoadjuvant treatment of HN SCC. The regimen was well tolerated in most
patients, and histological and clinical tumor responses were observed.

The current study utilizes the same IRX-2 regimen evaluated in a more recent Phase 1 trial
in patients with recurrent, refractory HN SCC performed at INCAN and the University of
Kentucky, where the safety of the IRX-2 regimen was studied and some evidence of clinical
activity was observed in 2 of 10 refractory patients.