Enrollment complete in Advaxis’ ADXS-HPV Phase 2 study on CIN 2/3

Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced today that it has completed enrollment of 40 patients in the second of three dose cohorts in Lm-LLO-E7-07, a randomized, single blind, placebo controlled Phase 2 dose escalation study assessing the safety and efficacy of ADXS-HPV for the treatment of cervical intraepithelial neoplasia (CIN) 2/3.    

The patients in cohort 2 were randomized 3:1 to ADXS-HPV (3 doses at 3.3x10⁸ cfu) or placebo. The dose of ADXS-HPV in this cohort is six times higher than that administered in cohort 1. Patients are observed for a total of 6 months after the last dose before undergoing the standard of care surgery (LEEP) required for the treatment of this disease. Safety and efficacy results will be reported once all patients have completed LEEP.

In February 2012, Advaxis announced the results from the first cohort of the trial, which consisted of 41 patients randomized 3:1 ADXS-HPV (3 doses at 5x10⁷ cfu) or placebo. In that cohort, 29% (9/31) of patients experienced side effects related/possibly related to treatment; no serious adverse events were experienced. 52% of CIN 2/3 lesions regressed from CIN 2/3 to CIN 1 or normal in the ADXS-HPV arm and 40% of CIN 2/3 lesions spontaneously regressed in the placebo arm. The rate of cervical lesion regression observed in cohort 1 is considered clinically meaningful by the standards of The American Academy of Clinical Research's Task Force on the Treatment and Prevention of Intraepithelial Neoplasia.

"Advaxis continues to meet major milestones in our clinical development plan," commented Dr. John Rothman, EVP of Science & Operations at Advaxis. "We look forward to assessing the results of the second cohort of this study and to advancing the development of ADXS-HPV for the treatment of HPV-associated diseases."