PRINCETON, N.J., Jan. 7, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced today that it 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 tumor 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 program with the U.S. 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, PhD, 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."
About cervical cancer
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% 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% of cervical cancer cases. The remaining 30% 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%, 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% of oral squamous cell carcinomas.
About GOG Foundation, Inc. (GOG Foundation)
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 U.S. 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.
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm-LLO platform technology. The Lm-LLO technology, using bioengineered live attenuated Listeria monocytogenes bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm-LLO immunotherapy, ADXS-HPV, targets human papillomavirus HPV-associated cancers and is in clinical trials for three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The FDA has granted Advaxis orphan drug designation for each of these three indications. The Company plans to initiate a registrational clinical program for cervical cancer in 2015 and has established licensing partners in India and Asia for commercialization in those regions. Advaxis entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, for a Phase 1/2 immunotherapy study to evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis's ADXS-HPV as a treatment for patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer.
Advaxis's second Lm-LLO immunotherapy candidate in clinical testing will be ADXS-PSA, which is being developed to address prostate cancer. Advaxis entered into a clinical trial collaboration agreement with Merck & Co., Inc. ("Merck"), known as MSD outside the United States and Canada, through its subsidiaries, to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's PD-1 checkpoint inhibitor Keytruda® (pembrolizumab). The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer.
Advaxis is also developing Lm-LLO immunotherapy ADXS-cHER2, to target the Her2 receptor overexpressing cancers. Her2 is overexpressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, esophageal, and gastric cancer. ADXS-cHER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-cHER2 for both human and animal-health, and has seen promising results in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis is planning to file an IND for ADXS-cHER2 in Her2 overexpressing cancers and to conduct a clinical program in pediatric osteosarcoma. Advaxis has licensed ADXS-cHER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for pet therapeutics.
For more information about our cancer immunotherapies please visit www.advaxis.com.
Some of the statements included in this press release, particularly those regarding the proposed Phase 3 for ADXS-HPV in patients with early stage cervical cancer, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis's proprietary immunotherapy, ADXS HPV; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
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