Advaxis, RTOG Foundation partner on Phase II/III trial of ADXS-HPV in anal cancer

RTOG Foundation’s partner NRG Oncology will be responsible for conducting the pivotal Phase II/III anal cancer trial of concurrent chemotherapy of mitomycin C/5FU and radiation therapy (CCRT) compared to CCRT combined with ADXS-HPV in the adjuvant treatment of high-risk locally advanced anal cancer.

ADXS-HPV is Advaxis’ investigational Lm-LLO immunotherapy designed to generate an immune response to the HPV-associated tumor specific oncogene.

RTOG Foundation chairman of the Board and NRG Oncology group chair Walter Curran said: "The ability of ADXS-HPV to generate an immune response to the HPV-associated tumor specific oncogene offers the potential to benefit multiple cancers that are known to be caused by the HPV infection, including cervical cancer and anal cancer.

"We look forward to initiating this Phase II/III study in anal cancer and mirroring the encouraging results that the Gynecologic Oncology Group, now a part of NRG Oncology, has had in its clinical study of ADXS-HPV in cervical cancer."

The US Food and Drug Administration (FDA) has also granted an orphan drug designation for ADXS-HPV for HPV-associated Stage II-IV cervical cancer, head and neck cancer, and anal cancer.

Advaxis executive vice president and chief medical officer David Mauro said: "Although a relatively rare tumor, virtually all cases of squamous cell cancer of the anus are caused by HPV infection, and ADXS-HPV offers the potential to treat this often fatal malignancy."

RTOG Foundation continues its National Cancer Institute (NCI) funded research activities through NRG Oncology and it also joins with corporate partners to conduct multicenter clinical trials systematically testing new radiotherapy approaches combined with new classes of anti-cancer therapies and targeted agents.