The Phase III trial is planned to be conducted in collaboration with the Gynecologic Oncology Group (GOG) Foundation and will be led by principal investigator from University of Cincinnati Cancer Institute Obstetrics & Gynecology professor and clinical director Thomas Herzog.
In the SPA request, the company has included specific questions to facilitate a meaningful dialog with the FDA on the proposed study design.
Advaxis executive vice-president and chief medical officer Dr David Mauro said: "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."
Following receipt, the agency will determine the appropriateness of the company’s SPA request and may take up to 45 calendar days to provide comments, which will determine the need for additional rounds of review and/or a formal meeting.
The proposed Phase III 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.
The company intends to commence the Phase III trial of ADXS-HPV by the end of this year.