Advaxis, Inc, a clinical-stage biotechnology company developing cancer immunotherapies, is entering into a clinical trial collaboration agreement with the GOG Foundation, Inc., (GOG Foundation), to evaluate the safety and efficacy of Advaxis'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 tumour specific oncogene.
Under the proposed collaboration, the GOG Foundation and Advaxis will conduct an adequate and well-controlled Phase 3 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. Prior to commencing this study, Advaxis will discuss the proposed phase 3 programme with the US Food and Drug Administration (FDA) and will update its investigational new drug (IND) submission. FDA may request additional information at that time, and Advaxis will work expeditiously to respond to any such requests.
Advaxis also plans to request a Special Protocol Assessment (SPA) from the FDA prior to commencing this collaborative study. A SPA is a declaration from the FDA that a phase 3 trial's design, clinical endpoints, and statistical analyses are supportive for FDA approval; however, the FDA makes final approval determinations following a complete review of data in a marketing application.
David J. Mauro, MD, executive vice president and chief medical officer of Advaxis, stated, "We look forward to collaborating with the GOG Foundation in order to further evaluate our lead immunotherapy in cervical cancer. 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."
The GOG Foundation is a world-renowned non-profit organization with the purpose of conducting clinical research for the prevention and treatment of all gynecologic cancers, such as ovarian cancer, cervical cancer, endometrial cancer, vulvar cancer, and vaginal cancer. Its members make up a multi-disciplinary group, consisting of gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, nurses, statisticians, and basic scientists.
Larry J. Copeland, MD, GOG foundation vice president, commented, "We are pleased to be entering into this collaboration with Advaxis. 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 gynecologic cancer patients with unmet needs. We look forward to getting this important study underway."
There are 500,000 new cases of cervical cancer caused by the human papilloma virus (HPV) worldwide every year according to the World Health Organization (WHO) Human Papillomavirus and Related Cancers in the World Summary Report 2010. According to the WHO, current preventative vaccines cannot protect the 20 million women who are already infected with HPV; and of the high risk oncogenic strains, only HPV 16 and 18 are present in these vaccines.
It is estimated that approximately 12,500 women a year are diagnosed with cervical cancer in the United States, and approximately 4,000 a year will succumb to the disease. Locally advanced cervical cancer, affecting approximately 36 per cent of patients at diagnosis (~4,500 in the US alone), has a market potential of $500 million. Cervical cancer is the first type of cancer found to be caused almost exclusively by a virus, the human papillomavirus (HPV). Two subtypes, HPV-16 and HPV-18, are responsible for 70 per cent of cervical cancer cases. The remaining 30 per cent of cervical cancer cases are associated with other HPV subtypes and will not be prevented by vaccination with the currently available HPV vaccines. With HPV vaccination rates in school-aged children significantly below the goal of 80 per cent, the need for novel cervical cancer therapies is high and will remain so for the foreseeable future.
Challenges with acceptance, accessibility, and compliance have resulted in only a third of young women being vaccinated in the United States and even less in other countries around the world. HPV is associated with 20-50 per cent of oral squamous cell carcinomas.
The GOG Foundation, Inc. (GOG Foundation) is an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. Continuous evaluation of our processes is utilized in order to constantly improve the quality of patient care. The GOG Foundation conducts clinical trials for patients with a variety of gynecologic malignancies, including cancers that arise from the ovaries, uterus, cervix, vagina, and vulva. The GOG Foundation is a separate entity from the National Clinical Trials Network groups that are funded by the National Cancer Institute.
ADXS-HPV is Advaxis's lead immunotherapy product candidate for the treatment of HPV-associated cancers. It is currently under investigation in three HPV-associated cancers: invasive cervical cancer, head and neck cancer, and anal cancer. In cervical cancer, a recently completed Phase 2 study of ADXS-HPV demonstrated improved survival and a manageable safety profile alone or in combination with chemotherapy, which warrants further development of the molecule. Clinical trials in head and neck cancer and in anal cancer are ongoing. The US Food and Drug Administration granted an orphan drug designation for ADXS-HPV for HPV-associated Stage II-IV cervical cancer, head and neck cancer, and for anal cancer.