Advaxis receives DSMB approval to complete dosing in first leg of ADXS11-001 cervical dysplasia clinical trial

The science team from Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, met with the Data Safety Monitoring Board (DSMB), an independent group of medical experts, yesterday and received approval to dose all remaining patients in the initial forty (40) patient leg of the 120-patient, cervical dysplasia clinical trial being conducted in the United States.

“Our lead construct, ADXS11-001, was well tolerated in all treated patients. The DSMB found no safety issues that warranted any change in the conduct of the trial.”

This meeting was a required step in the protocol agreed to with the U.S. Food and Drug Administration.

The 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.

"We are pleased with the pace of enrollment and the continued finding of safety in all Phase II participants," commented Advaxis EVP of Science and Operations Dr. John Rothman. "Our lead construct, ADXS11-001, was well tolerated in all treated patients. The DSMB found no safety issues that warranted any change in the conduct of the trial."

Overall, thirty-eight (38) patients have been dosed in two (2) trials. By year end, it is anticipated that there will be a database of more than 200 dosed patients."