![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » GMP MATERIALS READY FOR CERVICAL CANCER TRIAL
GMP MATERIALS READY FOR CERVICAL CANCER TRIAL
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.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
21Oct