Advaxis, a clinical-stage biotechnology company developing the next-generation of immunotherapies for cancer and infectious diseases, announced that the first patient has been dosed in a Phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer.
Coordinated by the Brown University Oncology Research Group (BrUOG), this study will expand the clinical investigation of ADXS-HPV to now a third tumor type, following cervical cancer and head and neck cancer. ADXS-HPV has been safely administered to more than 190 patients with HPV-associated diseases, and has demonstrated clinical benefit as a single agent or in combination with chemotherapy.
This non-randomized, open-label, multi-center study was designed to assess 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.
“This milestone marks the beginning of the development of ADXS-HPV in diseases beyond cervical cancer. It also will provide valuable insight into the combination of ADXS-HPV with concurrent radiation and chemotherapy,” commented Dr. Robert Petit, VP of Clinical Operations and Medical Affairs at Advaxis.
For more information, visit www.advaxis.com
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