Advaxis, Inc 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 therapy.
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 study begins.
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.
