Advaxis meets with FDA over planned Lovaxin C trials

By Elaine Rigoli

Tampa, Fla., Sept. 25 - After a meeting with the Food and Drug Administration regarding two planned phase 2 studies for Lovaxin C, a live Listeria vaccine for the treatment of cervical as well as head and neck cancers, Advaxis, Inc. said the FDA provided guidance for the submission of an Investigational New Drug application and future product development.

The North Brunswick, N.J.-based vaccine company said it has proposed phase 2 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 said it will measure time to progression and survival endpoints, immuno-genetic ability and safety parameters.

Preclinical data for Lovaxin C has shown an 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, the company said in a news release.

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