PRINCETON, N.J.--(BUSINESS WIRE)--Advaxis, Inc., (NASDAQ:ADXS), a leader in developing the next generation of cancer immunotherapies, announced that the first patient has been dosed in a Phase 1/2 “window of opportunity” study being conducted by the Icahn School of Medicine at Mount Sinai. Patients diagnosed with HPV-associated head and neck cancer will receive ADXS-HPV immunotherapy during the “window” of time between initial diagnosis and minimally invasive transoral robotic surgery (TORS) to remove their tumors. HPV-associated head and neck cancer is the most rapidly growing form of head and neck cancer, and is caused by the same virus that causes cervical cancer.
“This study will characterize the potential of ADXS-HPV to stimulate the patient’s own immune system to fight cancer prior to receiving TORS,” commented Dr. Robert Petit, Chief Scientific Officer of Advaxis. “The short and long-term side effects of surgery followed by chemotherapy and radiation can be disfiguring and interfere with the patient’s ability to swallow and eat. We have partnered with experts at one of the top head and neck cancer treatment centers in the world who share our goal of making more effective and less toxic treatments available for patients with this terrible disease. It is our shared hope that adding the power of our newly emerging immunotherapy to technological advances like TORS may significantly improve the treatment options and long-term outcomes for head and neck cancer patients and survivors.”
This investigator-initiated clinical study is designed to enroll 25 patients with human papillomavirus (HPV)-positive stage II-IV squamous cell carcinoma of the oropharynx who are scheduled to undergo TORS. TORS is an FDA-approved technology developed at Mount Sinai for patients with head and neck cancer and is considered to be the standard of care therapy in appropriate patients. Fifteen patients will receive ADXS-HPV treatment followed by TORS and ten patients will serve as the control group and receive only TORS. The primary objective of this study is to assess the safety, efficacy, and immunogenicity of ADXS-HPV in this patient population prior to undergoing surgery. The Mount Sinai immunology core lab will fully characterize the immunologic effects of ADXS-HPV treatment on both the patient and his or her tumors. If successful, ADXS-HPV could potentially be used before surgery or other cytotoxic treatments to reduce the dose of cytotoxic therapies, decrease toxicities, and enhance long-term disease control.
About ADXS-HPV in Head and Neck Cancer
ADXS-HPV is Advaxis’ lead immunotherapy product candidate for the treatment of HPV-associated cancers. It is currently under investigation in three HPV-associated cancers: 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. Clinical trials in head and neck cancer and in anal cancer are ongoing. Advaxis has received Orphan Drug Designation from the US Food and Drug Administration for ADXS-HPV for HPV-associated head and neck cancer and for anal cancer.
HPV-associated Head and Neck Cancers
More than 90% of head and neck squamous cell oropharyngeal cancers originate from the mucosal linings of the oral cavity, pharynx, or larynx. Currently, 60-80% of these cancers are caused by HPV. Head and neck cancers are treated by surgical removal of the cancer and lymph nodes, often followed by radiation and chemotherapy based on the extent of the disease. While patients may achieve good long-term survival, standard treatments can change their physical appearance and are associated with significant short and long-term toxicities which may interfere with salivary gland function, taste, smell, and the ability to swallow.
The incidence of HPV-associated head and neck cancers has been increasing at an epidemic rate, while head and neck cancers from other causes have been decreasing. According to the WHO, approximately 15-20% of the 400,000 new cases of head and neck cancer are HPV-related. In the US, there are about 12,000 new cases of HPV-associated head and neck cancer per year and it affects men about 3 times more frequently than women. HPV-associated head and neck cancer is growing fastest in developed countries like the US.
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing the next generation of cancer immunotherapies. Advaxis’ immunotherapies are based on a novel platform technology using live, attenuated bacteria to stimulate the immune system to selectively target cancer cells while reducing tumor defenses.
ADXS-HPV, Advaxis’ lead immunotherapy for the treatment of HPV-associated cancers, has improved survival and objective tumor responses in a Phase 2 trial in 110 patients with recurrent cervical cancer. Advaxis is now planning the registrational program for ADXS-HPV. ADXS-HPV is also being evaluated in other HPV-associated cancers including a Phase 2 in advanced cervical cancer, a Phase 1/2 in head and neck cancer, and a Phase 1/2 in anal cancer. ADXS-HPV has Orphan Drug Status for both anal and head and neck cancers. As part of its global commercialization strategy to enter into regional licensing deals with other market dominant biopharmaceutical companies in territories where there is a high prevalence of HPV-associated cancers, Advaxis has granted an exclusive license for the development and commercialization of ADXS-HPV in Asia.
ADXS-cHER2 is an immunotherapy for the treatment of HER2 overexpressing cancers (such as breast, gastric, and other cancers in humans and for osteosarcoma in canines). Advaxis’ lead animal-health immunotherapy, ADXS-cHER2, has demonstrated encouraging survival data in a Phase 1 trial in canine osteosarcoma. These data provide the rationale to advance this same immunotherapy into a Phase 1 clinical trial in women with HER2-positive breast cancer. The Company is preparing to submit an IND for ADXS-cHER2 in breast cancer in 2014.
Advaxis has created over 15 distinct immunotherapies based on its platform either directly or through strategic collaborations with recognized centers of excellence such as: the University of Pennsylvania, Brown University, the Georgia Regents University Cancer Center, the Icahn School of Medicine at Mount Sinai, and others.
This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis’ proprietary immunotherapy, ADXS-HPV; whether Advaxis immunotherapies can redirect the powerful immune response all human beings have to the bacterium to cancers. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis' SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2012, which is available at http://www.sec.gov. 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.