Inc., (OTCBB: ADXS), the live, attenuated Listeria
monocytogenes (Lm) vaccine company, will collaborate with the
Gynecologic Oncology Group (GOG), a collaborative research group of the
National Cancer Institute (NCI), in a multicenter, Phase II clinical
trial of the Company’s lead drug candidate, ADXS11-001 in the treatment
of advanced cervix cancer in women who have failed prior cytotoxic
This Phase II trial will be conducted by GOG investigators and largely
underwritten by the NCI. The study’s patient population – a very sick
and rapidly progressive patient population for whom no therapy has been
found to be effective – will be the same patient population that was
treated in Advaxis Phase I trial of ADXS11-001.
Advaxis will contribute the study drug and some funds to the cost of the
trial, including the translational clinical immunology research. Advaxis
will update its IND and file the final protocol with FDA before the
In an Advaxis Phase I clinical trial, it was found that multiple doses
of the agent were safely administered to this patient population at two
(2) different dose levels and that the side effect profile, comprised of
a flu-like syndrome, was consistent with strong immune stimulation.
Although this first-in-human trial was not powered for efficacy, it was
observed that the response rate and survival data compared favorably
with historical controls. The new study will investigate this response
with greater statistical power. The Phase I trial results were published
earlier this year in Vaccine (Vaccine. 2009, 27 3975–3983).
Advaxis has separately announced its plans of Phase II studies of
cervical cancer and cervical intraepithelial neoplasia (CIN), which are
anticipated to begin dosing shortly.