A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer

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

This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).

IRX-2 is a primary cell-derived biologic that reduces the immune suppression that is often seen in the cancer tumor micro-environment, restores immune function and activates a coordinated immune response against the tumor. IRX-2 is a complex proprietary therapeutic containing numerous active cytokine components, which restores and activates multiple immune cell types including T cells, dendritic cells, and natural killer cells to recognize and destroy tumors.

The present study administered the IRX-2 Regimen to 27 patients as a neoadjuvant (before surgery) therapy, and the main objective of the study was to determine the safety and tolerability of the IRX-2 regimen.

Inclusion Criteria:

• Pathologically confirmed (histology) Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
• No prior surgery, radiation therapy or chemotherapy of this tumor other than biopsy or emergency procedure required for supportive care.
• Clinically staged Stage II, III, or IVA cancer, assessed to be surgically resectable with curative intent.
• Life Expectancy of greater than 6 months

Exclusion Criteria:

• Stage IVB Squamous Cell Carcinoma
• Use of any investigational agent within the previous 30 days
• Uncontrolled cardiovascular disease
• Myocardial infarction within the last 3 months
• Abnormal hemoglobin, neutrophil, lymphocyte or platelet counts
• Positive for hepatitis B or C or HIV
• Evidence of distant metastases
• Clinical gastritis or peptic ulcer within the last 6 months
• Stroke within the last six months