IRX Therapeutics asserted that Phase 2 double-blind, randomized, placebo-controlled clinical trial of IRX-2 in women has commenced with squamous cervical intraepithelial neoplasia 3 (CIN3) or vulvar intraepithelial neoplasia 3 (VIN3).
RX-2 is a proprietary therapeutic containing numerous active cytokine components, which data suggests may restore and activate multiple immune cell types, including T cells, dendritic cells and natural killer cells, that are known to recognize and attack tumors. CIN3 and VIN3 are usually caused by certain types of human papillomavirus (HPV) and are found when a biopsy is done. If not treated, these abnormal cells may become cancerous and spread to nearby normal tissue. Overall, at least 75-80% of sexually active women will have acquired a genital HPV infection by age 50.
Lynda Roman, MD, Division of Gynecologic Oncology, USC Norris Comprehensive Cancer Care Center said “Current treatment options for severe cervical and vulvar intraepithelial neoplasia can cause substantial short-term morbidity as well as longer term risks to fertility, sexual function and pregnancy outcomes and so there is a great need for new treatment options.”
Mark Leuchtenberger, President and Chief Executive Officer, IRX Therapeutics claimed “An earlier pilot study in 10 patients with early stage cervical cancer demonstrated that IRX-2 was well tolerated with encouraging signs of efficacy. IRX-2 is currently being studied in multiple other indications including an international Phase 2b study in squamous cell cancer of the head and neck and an investigator-sponsored Phase 1b study in breast cancer.”
The CIN3 VIN3 study is a double blind, randomized, placebo-controlled trial. The IRX-2 regimen will include cyclophosphamide on Day 1 (three days before the start of IRX-2), IRX-2 daily for 4 days; and indomethacin, zinc with multivitamins, and a proton pump inhibitor (omeprazole) for 21 days. All treatments will be repeated at 6 weeks, for a total of two cycles. Patients will be randomized 2:1 to the treatment arm with the goal of enrolling 30 patients in the CIN3 cohort and 30 patients in the VIN3 cohort.