Advaxis said it's entering a clinical trial collaboration agreement with GOG Foundation, to evaluate the safety and efficacy of the company's lead cancer immunotherapy, ADXS-HPV, in a global Phase 3 cervical cancer trial. ADXS-HPV is an investigational Lm-LLO immunotherapy bioengineered to generate an immune response to the HPV-associated tumor specific oncogene. Prior to commencing this study, Advaxis will discuss the proposed Phase 3 program with the U.S. Food and Drug Administration and will update its investigational new drug (IND) submission.

The FDA may request additional information and Advaxis said it will work expeditiously to respond to any such requests. Advaxis also plans to request a Special Protocol Assessment from the FDA.