Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has submitted a protocol revision that has passed FDA review for the enrollment of the next 40 subject "mid strength" dose cohort in the dose-ranging Phase II study of ADXS-HPV, an immunotherapy for Cervical Intraepithelial Neoplasia (CIN).
The revised protocol eliminates a staggered dosing design that required two pauses in recruitment to evaluate the safety of all three doses in two successive small groups of patients. The pauses consumed about 5 months in the recently completed low dose cohort that took about 14 months to complete.
The ADXS-HPV CIN study is a randomized, single blind, placebo controlled Phase II dose-ranging study designed to assess the safety and efficacy in up to 3 different dose cohorts.
"We proposed the changes to FDA based on the encouraging safety profile that has emerged after 110 patients have been dosed with ADXS-HPV. This change, combined with the learning curve associated with any clinical study, should bring our mid dose results in much more quickly," commented Advaxis Executive Vice President John Rothman, PhD. "Recruitment for the mid dose cohort is well underway. Our plan continues to be to release the low dose results in early 2012."