Advaxis is entering into a clinical trial collaboration agreement with the Gynecologic Oncology Group (GOG) Foundation to evaluate safety and efficacy of the company's lead cancer immunotherapy ADXS-HPV in a global Phase III trial to treat cervical cancer.
ADXS-HPV is an investigational Lm-LLO immunotherapy designed to generate an immune response to the HPV-associated tumour specific oncogene.
Both parties will conduct an adequate and well-controlled Phase III clinical trial of concurrent chemotherapy and radiation therapy (CCRT) compared to CCRT combined with ADXS-HPV in women diagnosed with high-risk, locally advanced cervical cancer.
Advaxis executive vice-president Dr David Mauro said: "By evaluating ADXS-HPV in this high-risk, locally advanced setting early in the onset of the disease, we believe there is a greater potential to impact the course of early stage cervical cancer and survival of the patient."
Before starting the trial, Advaxis will discuss the proposed Phase III programme with US Food and Drug Administration (FDA) and will update its investigational new drug (IND) submission.
The company also intends to request a special protocol assessment (SPA), a declaration from the FDA that a Phase III trial's design, clinical endpoints and statistical analyses are supportive for FDA approval.
GOG Foundation vice-president Larry Copeland said: "The opportunity to evaluate the ADXS-HPV immunotherapy in women with cervical cancer is compelling and the GOG Foundation is committed to bring forward novel therapies to gynaecologic cancer patients with unmet needs."
The GOG Foundation is focused on conducting clinical research for the prevention and treatment of all gynaecologic cancers, such as ovarian cancer, cervical cancer, endometrial cancer, vulvar cancer, and vaginal cancer.