ADXS-"ADXS lead Lm immunotherapy, AXAL, is in clinical trials for three indications: invasive cervical cancer, head and neck cancer, and anal cancer. FDA has granted AXAL orphan drug designation in each indication as well as a special protocol assessment for phase 3 cervical cancer trials including fast track designation. AXAL is currently being evaluated in eight trials for HPV-associated cancers and has shown promising anti-tumor activity and acceptable tolerability in multiple trials. HPV (human papilloma virus) infection is present in the majority of cervical cancer. There are over a half of a million new cases of cervical cancer reported worldwide each year, with an estimated 266,000 deaths."