Avax seeks FDA approval for lung cancer drug trial

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http://www.pharmaceutical-business-revi ... B70163FA7A

AVAX Technologies has filed an investigational new drug application with the FDA to begin a phase I/II clinical trial using the company's drug candidate M-Vax to treat patients with stage I and II non-small cell lung cancer.

8 Sep 2005, 12:35 GMT - In the study, M-Vax, an AC vaccine therapeutic, will be given as a first-line treatment to non-small cell lung cancer (NSCLC) patients after surgery. The study endpoints include safety and a measure of cellular immunity known as delayed-type hypersensitivity (DTH) to the patient's own lung cancer cells.

If approved, the study is to be carried out in conjunction with researchers from the University of Pennsylvania.

"Based upon previous observations of regression of melanoma lung metastases after administration of M-Vax, our AC vaccine therapeutic for the treatment of melanoma, we feel there is a strong rationale for testing the vaccine in this indication," commented Dr David Berd, chief medical officer of Avax. "Moreover, the fact that NSCLC is a chemically-induced cancer makes it likely to be immunogenic and responsive to appropriate immunotherapy."

According to the company there are around 175,000 new cases of NSCLC each year in the US.

Source: Datamonitor Newswire