US-based clinical-stage biotechnology firm Advaxis has announced the start a Phase I/II trial of its lead immunotherapy drug candidate ADXS-HPV in 25 patients with human papillomavirus (HPV) positive head and neck cancer.
The Icahn School of Medicine at Mount Sinai (ISMMS) will be responsible for carrying out the clinical trial, which is aimed at assessing the effects of ADXS-HPV in patients who are initially diagnosed with HPV-associated head and neck cancer, prior to receiving any chemotherapy or radiation.
According to the company, the non-randomised investigator-initiated trial will be a major first step toward understanding the drug's potential to treat this type of cancer before chemotherapy or radiation and its potential to reduce the need for these treatments.
The trial has been designed to assess the safety and immunogenicity of ADXS-HPV in patients with HPV-positive stage II-IV squamous cell carcinoma of the oropharynx (OPCSC).
During the trial, 15 patients will be given ADXS-HPV treatment followed by ablative transoral robotic surgery (TORS), while the remaining ten patients will serve as the control group and receive only TORS, which is FDA-approved for head and neck cancer and is considered to be the standard of care therapy for OPCSC in appropriate patients.
ISMMS director of head and neck medical oncology Marshall Posner said: "We hope that this trial of a therapeutic HPV vaccine can help us set the stage for future immunotherapies that can eliminate the standard use of chemotherapy and radiotherapy as adjuvant treatments for HPV-caused oropharynx cancer."
Earlier this month, the company received orphan drug designation from the US Food and Drug Administration (FDA) for ADXS-HPV for HPV-associated head and neck cancer.
In a recently completed Phase II trial, ADXS-HPV had achieved proof-of-concept, showing encouraging clinical activity and a manageable safety profile in patients with recurrent cervical cancer.
Advaxis chief scientific officer Robert Petit said the trial will be the first in which the company can assess the effects of ADXS-HPV in patients when they are newly diagnosed with cancer and treat them with ADXS-HPV immunotherapy prior to any chemotherapy or radiation.
"Evaluating ADXS-HPV in this clinical trial is an important first step toward understanding the potential role of ADXS-HPV immunotherapy in treating these patients' cancer early and altering the course of their disease before any treatment with or radiation and/or chemotherapy, which can have difficult, life-altering consequences," Petit said.
ADXS-HPV is used to generate a robust immune response, break immune tolerance to cancer and produce an unusually strong and effective multi-level therapeutic immune response to existing cancer and other diseases.
It is a live attenuated Listeria cancer vaccine that is administered intravenously.
ADXS-HPV is currently under development for the treatment of cervical dysplasia, cervical cancer, cervical intraepithelial neoplasia, oropharyngeal carcinoma, anal cancer and head and neck cancers that result from the HPV.
Image: Electron micrograph of a negatively stained human papilloma virus (HPV) which occurs in human warts. Photo: courtesy of Patho.