ADXS-HPV: Preliminary Phase I/II data

Preliminary data from an open-label Phase I/II trial in patients with HPV-associated anal cancer with a high risk of recurrence showed that ADXS-HPV plus standard chemotherapy and radiation led to a complete clinical response in all 7 patients who completed treatment. Flu-like symptoms were the most common adverse event reported. Brown University Oncology Research Group is conducting the trial, which is enrolling 25 patients. Advaxis said the addition of ADXS-HPV to standard chemotherapy and radiation will be considered promising if the 6-month complete response rate is >80%. Next year, Advaxis plans to start Phase III testing of ADXS-HPV to treat recurrent cervical cancer. The product is also in Phase I/II testing for HPV-associated head and neck cancer. ADXS-HPV has Orphan Drug designation in the U.S. to treat stage II-IV invasive cervical cancer, HPV-associated anal cancer and HPV-associated head and neck cancer. ...