First patient dosed in Phase III AIM2CERV trial evaluating axalimogene filolisbac as an adjuvant therapy for high-risk, locally advanced, carcinoma of the cervix. -Advaxis

Advaxis, Inc. announced that the first patient has been enrolled and dosed in its AIM2CERV (Advaxis IMmunotherapy 2 prevent CERVical recurrence) trial, the only company-sponsored global phase III trial enrolling patients with advanced stage cervical cancer. AIM2CERV is a global, randomized, 450-patient study evaluating axalimogene filolisbac as an adjuvant therapy following primary treatment with chemotherapy and radiation in patients with high-risk locally advanced carcinoma of the cervix (HRLACC).

The primary objective of the trial is to compare disease-free survival (DFS) in patients receiving axalimogene filolisbac to DFS in patients receiving placebo, with secondary objectives including overall survival, safety and tolerability. AIM2CERV is being conducted in collaboration with the GOG Foundation, Inc. under a Special Protocol Assessment (SPA) agreement with FDA.

Comment:There are 528 000 new cases of cervical cancer reported each year with 260 000 related deaths. Median cervical cancer survival is 13 to 17 months with first line platinum chemotherapy with or without Avastin but women who progress usually only have 4-7 months survival after first line therapy failure. There are no approved second line treatments.