Advaxis (ADXS), a biotechnology company, said Stage 1 data in a Phase 2 trial showed treatment with its axalimogene filolisbac resulted in a 38.5% percent 12-month overall survival rate in 26 patients with persistent or recurrent metastatic cervical cancer.
Safety data showed that Grade 1 or 2 adverse events occurred in 73% of patients, with four patients experiencing a Grade 3 adverse event (hypotension and cytokine release syndrome) and one patient experiencing a Grade 4 adverse event (lung infection and sepsis).
Advaxis has submitted a Special Protocol Assessment request to the U.S. Food and Drug Administration for a Phase 3 study evaluating the safety and efficacy of axalimogene filolisbac in high-risk, locally advanced cervical cancer. The trial will be conducted in collaboration with the GOG Foundation and is intended to begin enrollment by the end of 2015.
A completed randomized Phase 2 trial of axalimogene filolisbac with or without cisplatin chemotherapy in Indian patients previously demonstrated a 12-month overall survival rate of 32% and acceptable tolerability with chills and flu-like symptoms the most common treatment-related adverse events.
Shares of ADXS are at $19.71 within a 52-week range of $2.50 – $30.13.