The patient enrollment commenced after dosing 15 patients in an escalating dose clinical trial that was conducted in Mexico, Serbia and Israel. The objective of this trial was to establish a range of safe doses up to a maximally tolerated dose, which has been achieved.
Advaxis plans to complete patient reporting in July, report the results over the following 2 months, and submit an IND for Lovaxin C to the FDA by October, 2007. If the IND is approved, it would be followed by additional phase II clinical trials in the US and internationally.
New Jersey-based Advaxis is developing therapeutic cancer vaccines that enhance the immune system’s cancer-fighting abilities through its proprietary Listeria monocytogenes based system, which utilizes two immunological mechanisms (innate and classical immunity) to develop safer and more effective Listeria based cancer vaccines.