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.

“An earlier pilot study in ten patients with early stage cervical cancer demonstrated that IRX-2 was well-tolerated with encouraging signs of efficacy.”

The trial’s primary endpoint is pathological objective response at week 25.

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IRX 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.