DCGI approves ADXS11-001 human testing for cervix cancer

As part of approving the human testing of ADXS11-001— the lead agent for the treatment of cervix cancer of Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company — the Drugs Controller General of India (DCGI) required that the agent be tested to assure its safety prior to use. Testing will be completed in ten days and patient dosing will begin.

“This design advances the clinical development of ADXS 11-001 greatly in a number of ways”

Currently nine (9) centers have been enrolled and have begun to screen patients with advanced, metastatic cervix cancer for enrollment in this trial. These centers include Tata Memorial, Apollo Hospitals and other centers of medical research excellence in India. Full enrollment is anticipated in approximately three (3) months after the DCGI releases the drug for human use.

"This design advances the clinical development of ADXS 11-001 greatly in a number of ways," said Dr. John Rothman EVP of Science and Operations. "If we can duplicate the results of our phase I or improve upon them with three (3) doses of our agent compared to two(2) doses in Phase I, or find improved outcomes with chemotherapy, we would be able to show ADXS11-001 to be a safe and effective therapeutic agent where no alternatives exist."