Advaxis commences enrollment in ADXS-HPV Phase 1/2 study for head and neck cancer

Cancer Research UKMay 8 2012

Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that two patients have been enrolled into REALISTIC, a Phase 1/2 study being sponsored by Cancer Research UK (CRUK) to investigate the use of ADXS-HPV for the treatment of HPV positive head and neck cancer. HPV is associated with 40-70% of head and neck cancers.

This trial is being conducted at the Aintree Hospital at the University of Liverpool, the Royal Marsden Hospital at the University of London, and the Cardiff Hospital at the University of Wales. The study will investigate the safety and efficacy of this novel immunotherapeutic agent in preventing recurrence of head and neck cancer among patients who have been treated with surgery, radiotherapy, and/or chemotherapy; alone or in combination. A maximum of 45 patients are to be enrolled in this study, and all costs will be assumed by CRUK. Two patients have already been enrolled in the trial at the Aintree Hospital in Liverpool, UK.

Thomas A. Moore, Chairman & CEO of Advaxis commented, "We are pleased to be working with an internationally-renowned oncology group to further expand the ADXS-HPV clinical development program to another HPV-associated tumor type. Through this collaboration, we hope that our proprietary technology will be able to offer a new treatment option to patients suffering from the recurrence of head and neck cancer, an important unmet medical need."

According to the National Cancer Institute and the American Cancer Society, head and neck cancers represent approximately 3 percent of all cancers in the United States and are twice as common in men as in women. Historically, head and neck cancer has been associated with people over the age of 50 and with the use of alcohol and tobacco (including smokeless tobacco), however, there has been a recent rise in HPV-related oropharyngeal cancers in caucasian men under the age of 50. Recurrence rates in patients are high, in some studies over 80% within 2 years