Advaxis, a clinical-stage biotechnology company developing the next-generation of immunotherapies for cancer and infectious diseases, announced that the Brown University Oncology Research Group (BrUOG) has been chosen to coordinate a Phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer. Dr. Howard Safran, professor of medicine, will be principal investigator. Patients will be treated at Rhode Island Hospital and The Miriam Hospital (the main teaching hospitals of The Warren Alpert Medical School of Brown University). Multiple institutions will collaborate.
This non-randomized, open-label, multi-center study will evaluate the safety and effectiveness of ADXS-HPV when combined with standard chemotherapy and radiation treatment for anal cancer. The primary objectives of the trial include the evaluation of adverse events and the evaluation of 6-month clinical response. The study is expected to open for enrollment February 2013.
“We are pleased that the Brown University Oncology Research Group is coordinating this study in anal cancer using Advaxis’ lead construct ADXS-HPV,” commented Dr. Robert Petit, Vice President of Clinical Operations & Medical Affairs at Advaxis. “This study is an important first step in evaluating the combination of ADXS-HPV immunotherapy with the standard of care in HPV-associated cancers like anal cancer. The investigation of ADXS-HPV across a number of indications and in combination with other therapies will help us learn how best to use Advaxis immunotherapy to benefit patients with HPV-associated cancers. The anal cancer study will continue to build the safety and efficacy profile of our immunotherapy platform.”
Virtually all cases of squamous cell cancer (SCC) of the anus are caused by a Human Papilloma Virus (HPV) infection. Anal cancer cells infected with HPV have the tumor associated antigen HPV E7. ADXS-HPV causes antigen presenting cells to stimulate other immune cells to attack cancer expressing HPV E7. In Phase 1 clinical trials and preliminary data from ongoing Phase 2 trials, ADXS-HPV has been safely administered to 193 patients with other HPV-associated diseases (recurrent/refractory cervical cancer and CIN 2/3), and it has demonstrated clinical benefit as a single agent or in combination with chemotherapy.
For additional information, visit www.Advaxis.com
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