On October 15, 2014 Advaxis reported 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 (Press release Advaxis, OCT 15, 2014, View Source [SID:1234500828]).

“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.”

Conducted by BrUOG, the Phase 1/2 trial is a non-randomized, open-label, multi-center study of 25 patients designed to determine the safety and effectiveness of ADXS-HPV when combined with standard chemotherapy and radiation treatment for anal cancer in patients who have a high risk of recurrence based on their disease. The primary efficacy objective of the study is to assess the proportion of patients maintaining a clinical complete response at the 6 month mark. Based on historical clinical experience in similar high risk patients and pursuant to the study protocol, the addition of ADXS-HPV will be considered promising if the 6 month complete response rate is greater than 80%.

At present, 7 of 8 patients out of the planned total accrual of 25 patients have completed the treatment regimen. The 7 patients are without evidence of disease. Preliminary safety findings indicate flu-like symptoms were the most common adverse reaction lasting for about 24 hours.

Patients have been treated at Rhode Island Hospital and The Miriam Hospital (the main teaching hospitals of The Warren Alpert Medical School of Brown University). With these results, the study is being expanded to Ohio State University and Rutgers University, and these sites are in the process of activation.

Daniel J. O’Connor, President and CEO of Advaxis, remarked, “Though we recognize that the data is preliminary, it suggests a positive therapeutic response in the treated patients that warrants further investigation. Our strategy is to provide an immunotherapeutic treatment option to patients with HPV-associated anal, cervical and head & neck cancer – each of which Advaxis has obtained orphan drug status.”