Approximately 25 patients suffering from late-stage head and neck cancer will be recruited for IRX Therapeutics’ phase II trial, involving clinical sites in the US and in Mexico.
This study will seek to confirm the response results obtained in earlier studies, which suggest the effectiveness of IRX-2 in improving survival in this patient group. IRX-2 received fast track designation by the FDA in November 2003.
“More than 40,000 people in this country are diagnosed with head and neck cancer each year,” said John Spitznagel, chairman of IRX Therapeutics’ board of directors. “For patients with late-stage head and neck cancer, there is an “unmet medical need” for which the IRX-2 therapy is being studied.”
An earlier open-label phase II clinical trial in late-stage head and neck cancer patients demonstrated statistically significant improvement in the treatment group. After forty-eight months, the overall survival of IRX-2 treated patients was 61% versus 32% for the case-matched control group. Results of earlier phase II trials suggest that the treatment stimulates T-cell mediated anti-tumor activity. In these studies, IRX-2 appeared to be well tolerated with no reported serious product-related adverse events.