ADXS | Advaxis Receives Comments From FDA About Lovaxin C

1000 Penny Stocks News RoundUp

Response to the Company's IND for Its Lead Drug Candidate, Lovaxin C, For the Treatment of Cervical Intraepithelial Neoplasia

Jul 29, 2008 8:30:00 AM
Copyright Business Wire 2008

Advaxis Inc., (OTCBB: ADXS), a developmental biotechnology company, received comments from the U. S. Food & Drug Administration (the "FDA") regarding its Investigational New Drug ("IND") application for Lovaxin C, the Company's lead drug candidate, which was filed with a proposed Phase II study for the treatment of Cervical Intraepithelial Neoplasia ("CIN").

The FDA's first written response letter, received last week, addressed preclinical, manufacturing, microbiologic, immunologic and clinical questions concerning Lovaxin C and its therapeutic use in CIN and cervical cancer caused by the sexually transmitted human papilloma virus ("HPV"). The FDA also requested additional justification for the first proposed Phase II study in this indication and the potential risks and benefits of the proposed therapy relative to the current surgical standard therapy.

"We will respond to these requests in short order," commented Advaxis Chairman & CEO Thomas Moore. "In the interim, the proposed Phase II study is on clinical hold as we work closely with the FDA to address their concerns."

A recently completed Phase I trial of Lovaxin C addressed advanced, recurrent cervical cancer with distant metastases among patients who had failed prior therapy. This trial of 15 patients administered multiple doses of Lovaxin C to patients with advanced disease. Advaxis plans to conduct additional work with Lovaxin C in cervical cancer treatment in collaboration with the National Cancer Institute (the "NCI") beginning in early 2009.