FAQs

Q. WHY IS THE IRX-2 NEOADJUVANT REGIMEN ADMINISTERED LOCALLY?

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.

Q. WHY IS THE IRX-2 NEOADJUVANT REGIMEN INITIATED PRIOR TO CURATIVE SURGERY?

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.

Q. THE IRX-2 BOOSTER REGIMENS SEEM TO MAKE RECEIVING TREATMENT WITH IRX-2 MORE TIME-CONSUMING. CAN THEY BE SKIPPED?

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.

Q. THIS STUDY REQUIRES MY PATIENT TO BE AWAY FROM HOME FOR UP TO 2 WEEKS AND FOR SEVERAL TIMES. WILL SOMEONE PAY FOR THAT?

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.

Q. THIS IS AN IMMUNOTHERAPEUTIC REGIMEN BUT IT STARTS WITH CYCLOPHOSPHAMIDE. WON’T THAT INHIBIT THE IMMUNE RESPONSE?

A. One mechanism to reversing nonresponse and suppression of immune responses in subjects with malignancy is to inhibit suppressor T-cell function.1,2 Evidence indicates that cyclophosphamide inhibits suppressor or T regulatory cell (Treg) number and/or function.3 Thus, a number of clinical trials that involve immunotherapy or attempt to stimulate immune response to tumor antigens have employed a relatively low dose of cyclophosphamide (300 mg/m2) as a component of the treatment regimen.

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

© 2016 IRX Therapeutics