Advaxis, Inc. has announced preliminary data from its phase 1/2 study of ADXS-HPV, an investigational immunotherapy, in combination with standard chemotherapy and radiotherapy for the treatment of patients with human papillomavirus (HPV)-associated anal cancer who have a high risk of recurrence.
The researchers of the study observed a clinical complete response in all seven patients who completed the treatment regimen. For the phase 1/2 non-randomized, open-label, multicenter study, researchers enrolled 25 patients in order to determine the safety and efficacy of ADXS-HPV in this patient population. The primary endpoint of the study was to determine the number of patients maintaining a clinical complete response at 6 months after initial treatment.
Currently, seven patients have completed the entire treatment regimen and all are without evidence of disease. The most common adverse effect observed thus far has been flu-like symptoms which typically last for approximately 24 hours. Due to the positive preliminary results, the study will be expanded to other centers.
ADXS-HPV has been designated orphan drug status for the treatment of HPV-associated anal, cervical, and head and neck cancer by the U.S. Food and Drug Administration (FDA) and is currently being studied in multiple clinical trials.
Advaxis, Inc., a clinical-stage biotechnology company developing cancer immunotherapies, today announced preliminary data from its Phase 1/2 study of ADXS-HPV in human papillomavirus (HPV) associated anal cancer that indicate a “clinical complete response” in all 7 patients who have completed the treatment regimen.
“We are pleased with this preliminary data,” commented Dr. Howard Safran, Medical Director of Brown University Oncology Research Group (BrUOG) and principal investigator of the study. “We are now in the process of opening this study at other institutions.” Read more: http://www.benzinga.com/news/14/10/4923192/advaxis-provides-clinical-update-for-phase-12-trial-of-adxs-hpv-immunotherapy-pro#ixzz3GEJFEcR6