Advaxis has submitted its investigational new drug (IND) application to the FDA in May 2008, which outlined the proposed protocol for a Phase II clinical trial safety study targeting cervical intraepithelial neoplasia (CIN), a precursor condition to cervical cancer, commonly diagnosed by pap smears.
The proposed trial, unlike Advaxis Phase I cervical cancer trial, will target the disease at a much earlier stage of development and recruit CIN patients living in the US that are otherwise healthy. Due to the different patient population, the FDA requested more information to support the safety of Lovaxin-C and the methods used in its manufacture, which prompted the clinical trial hold.
John Rothman, vice president of Science & Operations at Advaxis, said: This study is a blinded, randomized and placebo-controlled trial of sufficient size; to build upon the promising results of our Phase I study in metastatic cervical cancer patients. In this study however, we are treating healthier women with stronger immune systems and with much less disease burden.
We believe that this work will provide us with meaningful support that our live, Listeria-based drug delivery system can safely resolve CIN before it becomes invasive cervical cancer, and without the adverse events that currently attend surgical treatment. The company anticipates commencing the trial in the second or third quarter of 2009.