AVAX Technologies Inc. kicked off a pivotal Phase III study of M-Vax, its AC Vaccine candidate, in metastatic melanoma patients.

The trial, which is being conducted under a special protocol assessment agreement with the FDA, is expected to enroll up to 387 patients with Stage IV melanoma who have soft-tissue or lung metastases.

They will be randomized on a 2-to-1 basis to the treatment arm, which will consist of M-Vax followed by a regimen of low-dose interleukin-2 (IL-2), or the control arm, which will consist of placebo vaccine followed by the IL-2 treatment. Both arms include BCG and low-dose cyclophosphamide.

The study is designed to examine survival and response rate as measured by modified response evaluation criteria in solid tumors (the modified RECIST criteria.)

Upon achieving the response rate endpoint, Philadelphia-based AVAX will be able to file for accelerated approval of M-Vax, under the terms of the SPA. The company expects patient enrollment to take about 24 months, and anticipates an interim analysis in 2009.

M-Vax, which is designed to work as an immunotherapy in postsurgical treatment of late-stage melanoma, is the lead program to emerge from the firm's AC Vaccine technology.

That platform calls for the creation of a vaccine based on a patient's tumor. By extracting cancer cells and treating them with dinitrophenyl, AVAX said it is able to prepare a vaccine that should be able to elicit a systemic immune response to the unmodified, native cancer cells.

Results from an earlier Phase II study showed that M-Vax induced tumor shrinkage in 11 of 83 patients with surgically incurable Stage IV melanoma.

Additional data demonstrated that patients treated with the modified tumor cells, using manufacturing techniques similar to those that produce M-Vax, achieved a response rate of 35 percent when followed with low-dose IL-2.

Shares of AVAX (OTC BB:AVXT) fell 2 cents Tuesday to close at 10 cents.