FDAnews
www.fdanews.com/articles/75204-gmp-materials-ready-for-cervical-cancer-trial

GMP MATERIALS READY FOR CERVICAL CANCER TRIAL

August 9, 2005

Advaxis announced that its GMP clinical materials have passed quality control release and are available for use in a Phase I/II clinical trial of Lovaxin C in advance cervical cancer patients.

This study will be the first time a live Listeria vaccine is used as a therapeutic agent in cancer. Twenty patients receiving one of four different doses will be assessed for safety and tolerance. Efficacy of Lovaxin C will be assessed across various parameters, including tumor measurements and immunologic responsiveness.

The manufacturing process, which is a fermentation of Advaxis' live Listeria construct, generated sufficient material to provide enough doses to support the Lovaxin C clinical program in Cervical and Head & Neck cancers through Phase I and Phase II, and possibly into Phase III.