NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)--Advaxis, Inc. (OTCBB: ADXS) has conducted a pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding its two planned Phase II studies for its lead product Lovaxin C, a live Listeria vaccine for the treatment of cervical as well as head and neck cancers. The FDA has reviewed information provided by the Company on its methods, procedures and results to date, and provided guidance for the submission of an investigational new drug (IND) application and future product development. The Company has proposed Phase II trials in cervical and head and neck cancers that are each expected to consist of 60 early stage cancer patients. The objectives of these trials are to assess the regimens for the safety and efficacy of Lovaxin C. In both trials the Company will measure time to progression and survival endpoints, immuno-genetic ability, and safety parameters. Pre-clinical data for Lovaxin C has shown an extremely efficacious immune response to tumors upon administration of the drug with an overall response rate of 100% and complete eradication of tumors in more than half of the animals tested.
