IRX-2 2005-A Trial

The recent multi-center Phase 2 study, IRX-2 2005-A, of 27 unrandomized patients was conducted at 15 sites in the United States and 1 site in Mexico. The objective of this latest study was to demonstrate the safety and biologic activity of IRX-2 in newly diagnosed head and neck squamous cell carcinoma (“H&NSCC”) patients.

Newly diagnosed head and neck cancer patients were treated with the IRX-2 regimen as a neoadjuvant therapy (treatment prior to curative cancer surgery). The vast majority of patients had locally advanced disease, Stage III or IVa. After all patients had been followed for at least two years, median overall survival has not been reached. At 24 months of follow-up in the Stage IVa cohort, eleven of sixteen patients, or 69%, of IRX-2 treated patients were alive. As a small unrandomized trial, efficacy conclusions cannot be drawn from this study. A large randomized trial is needed to determine whether or not IRX-2 prolongs survival.

IRX-2 2004-B trial

IRX-2 2004-B was a Phase 1 study conducted under the U.S. IND at two clinical sites, the Instituto National de Cancerologia (“INCAN”) in Mexico City, Mexico and the University of Kentucky. This study enrolled 13 patients and the drug was tolerated.