Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, has completed the nine (9) doses to be administered to the three (3) vanguard patients in the low dose group of its phase II cervical dysplasia clinical trial study.
As per the FDA approved design for this trial, an initial group of 3 patients in each dosing group is to be treated and observed to assure safety before proceeding to enroll the remaining patients in each dosage group. This milestone has been achieved for the first group. No adverse events associated with the ADXS11-001 administration were observed in any patient.
The protocol also requires that after a total of ten (10) patients are treated in a dosing group, an independent Drug Safety Monitoring Board (DSMB) will assess the safety responses of the treated patients before allowing the remaining thirty (30 patients in the group to be enrolled. Sufficient patients have already been screened to allow for rapid enrollment of all patients necessary to have the DSMB meeting.
Advanced cervical dysplasia leads to invasive cervix cancer. This trial follows from the promising findings in the ADXS11-001 Phase I trial in late stage cervix cancer.