Advaxis Submits Special Protocol Assessment Request to FDA for ADXS-HPV Phase 3 Clinical Trial in Cervical Cancer

Advaxis, Inc. ADXS, a clinical-stage biotechnology company developing cancer immunotherapies, today announced the company has submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) to initiate detailed design discussions for a Phase 3 clinical study of ADXS-HPV for the treatment of high-risk, locally advanced cervical cancer (HRLACC). The Phase 3 trial is planned to be conducted in collaboration with the Gynecologic Oncology Group (GOG) Foundation, Inc. and to be led by principal investigator Thomas Herzog, M.D., Professor of Obstetrics & Gynecology and Clinical Director at the University of Cincinnati Cancer Institute, Cincinnati, Ohio. The SPA request includes specific questions from Advaxis to facilitate a meaningful dialog with the FDA on the proposed study design. Following receipt, the FDA will determine the appropriateness of the SPA request and may take up to 45 calendar days to provide comments to Advaxis. The nature and extent of comments received will determine the need for additional rounds of review and/or a formal meeting. The FDA's assessment of the SPA request, and all related valuable feedback, will aid to inform the development of ADXS-HPV in locally advanced cervical cancer. The proposed Phase 3 clinical trial (AIM2CERV) is designed as an adequate and well-controlled double-blind, placebo-controlled multinational study of ADXS-HPV (ADXS11-001) administered in the adjuvant setting following concurrent chemoradiation given with curative intent in patients with HRLACC for whom recurrence has not yet occurred. Advaxis plans to initiate the Phase 3 trial by the end of 2015. "Submitting our SPA request to the FDA is an important first step in the proposed Phase 3 program for ADXS-HPV in cervical cancer," said David J. Mauro, M.D., Ph.D., Executive Vice President and Chief Medical Officer of Advaxis. "The decision to evaluate ADXS-HPV in HRLACC is based on the encouraging survival data observed in metastatic cervical cancer (Lm-LLO-E7-15 and GOG-0265)' and emerging clinical data on the adjuvant use of ADXS-HPV in the treatment of high-risk locally advanced anal cancer; and the adjuvant use of ADXS31-164 in canine osteosarcoma. We believe that ADXS-HPV may have an opportunity to demonstrate a more meaningful clinical impact on the lives of women with cervical cancer in an earlier disease setting and in a subpopulation of patients who are at high risk for recurrence."