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news.Advaxis, a developmental biotechnology company, has filed a new investigational new drug application with the FDA. This filing follows the successful completion of a Phase I study overseas.
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This application includes a Phase II protocol for Lovaxin C, Advaxis’s lead drug candidate, for the treatment of cervical intraepithelial neoplasia (CIN) to be conducted in the US. The filing requires a certificate of analysis for the company’s second clinical batch, which is currently being made and is anticipated to be complete within the next few weeks. The CIN study is scheduled to begin this summer pending the completion of the investigational new drug (IND) application and approval by the FDA.
CIN is a cervical condition caused by a sexually transmitted virus called the human papilloma virus that can lead to invasive cervical cancer, if not diagnosed properly and left untreated.
Tom Moore, chairman and CEO of Advaxis, said: “We are encouraged by our Phase I results, and our ability to generate novel immunotherapies with considerable activity in animal models. Additional clinical trials with Lovaxin C and the introduction of new immunotherapies into clinical trials are planned.”