Advaxis has received approval from the New England Institutional Review Board (IRB) to enroll the first patient in a phase II clinical trial of cervical dysplasia (cervical intraepithelial neoplasia or CIN).
Reportedly, in the phase II clinical trial, patients will receive three administrations of ADXS11-001 at monthly intervals. Six months after receiving their first dose, they are expected to receive the standard of care for the treatment of their disease, which is surgery.
The company said that the efficacy will be determined by comparing pre-treatment biopsy samples with surgical tissue samples. General observations to be made in the trial include that of patients’ health and well being, progression and state of disease, and clinical immunology.
The experimental protocol calls for 30 patients in each group to be treated, for a total of 120 patients. ADXS11-001 dosage groups include two doses that are lower than previously administered and one at the lowest dose administered in phase I.