A. The IRX-2 Neoadjuvant Regimen is administered locally to promote uptake of endogenous tumor peptides by dendritic cells (DCs) and subsequent T-cell activation during the first treatment cycle.
A. In head and neck squamous cell carcinoma, the IRX-2 biologic is injected into the mastoid region and drains into the lymphatic vessels, where physiologic quantities of IRX-2 restore the lymph node microenvironment and enable DCs to activate T cells against endogenous tumor peptides that have drained to the lymph node. This step must occur before curative surgery, during which the lymph nodes are removed.
A. No, the IRX-2 Booster Regimens cannot be skipped. They are an integral part of treatment with IRX-2, as it is currently being investigated. The objective is to optimize the outcome of IRX-2 therapy.
A. Accommodations will be provided or reimbursed for patients whose location requires them to be away from home, as will other travel and living expenses as appropriate based on distance and situation.
The single immunomodulatory dose is less than one-third of a typical anticancer dose and has minimal toxicity. It is not likely to have substantial myelosuppressive or direct antitumor effects, but rather is intended to enhance the development of cell-mediated immunity by providing contrasuppression of tumor-associated immune suppression (to reduce the number and function of suppressor T cells).4-7