IRX Therapeutics has dosed the first patient in a Phase ll trial of IRX-2 in women with squamous cervical intraepithelial neoplasia 3 (CIN3) or vulvar intraepithelial neoplasia 3 (VIN3).
The double-blind, randomised, placebo-controlled clinical study expects to investigate the potential of IRX-2 to restore the immune system of women diagnosed with CIN3 or VIN3 to prevent recurrent dysplasia.
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The IRX 2 regimen of the study will include cyclophosphamide on day one (three days prior to the beginning of IRX 2), IRX 2 daily for four days; and indomethacin, zinc with multivitamins, and a proton pump inhibitor (omeprazole) for 21 days.
IRX Therapeutics will repeat all treatments at six weeks for a total of two cycles.
Patients will be randomised 2:1 to the treatment arm, while both the CIN3 and VIN3 cohorts of the study expect to enrol 30 patients each.
The trial’s primary endpoint is pathological objective response at week 25.
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By GlobalDataIRX Therapeutics president and CEO Mark Leuchtenberger said: “We believe there is a strong mechanistic and clinical rationale for studying IRX-2 in the treatment of CIN3 and VIN3.
“An earlier pilot study in ten 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 IIb study in squamous cell cancer of the head and neck and an investigator-sponsored Phase lb study in breast cancer.”
IRX is conducting the Phase ll trial at the University of Southern California (USC) Comprehensive Cancer Centre in Los Angeles, California, US.
