Advaxis announced the approval of the Data Safety Monitoring Board (DSMB) to dose all remaining patients in its Phase 2 trial of ADXS11-001 for the treatment of cervical dysplasia. The trial’s protocol, agreed to by the FDA, required that an initial group of patients be treated and assessed by a DSMB prior to enrolling the full complement of patients in each forty (40) patient group. The company’s technology platform uses modified Listeria monocytogenes to deliver a tumor-specific antigen fusion protein.
ADXS11-001 is a therapeutic vaccine that treats women who have already developed cervical cancer as a result of human papilloma virus (HPV) infection.
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