Phase 2 study of ADXS11-001 for advanced cervical cancer

Advaxis announced that it will collaborate with the Gynecologic Oncology Group (GOG) in a Phase 2, multicenter clinical trial of ADXS11-011 for the treatment of advanced cervical cancer in women who have failed prior cytotoxic therapy. The patient population for this study will be the same population that was treated in the Advaxis Phase 1 clinical trial of ADXS11-011.

In the Phase 1 study, multiple doses of ADXS11-011 were safely administered at two different dose levels. The side effect profile, comprised of a flu-like syndrome, was consistent with strong immune stimulation. Although this first-in-human trial was not powered for efficacy, it was observed that the response rate and survival data compared favorably with historical controls. The Phase 2 study will investigate this response with greater statistical power.

ADXS11-001 is a therapeutic vaccine being investigated for the treatment of human papillomavirus (HPV) related tumors. Advaxis has also planned a Phase 2 study of ADXS11-011 for cervical intraepithelial neoplasia (CIN), which is anticipated to begin dosing shortly.

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