AVAX Technologies, Inc. Announces the Initiation of Its Phase III Registration Trial of M-Vax(R) in Metastatic Melanoma

PHILADELPHIA & LYON, France--(BUSINESS WIRE)--AVAX Technologies, Inc. (OTCMarket:AVXT.OB) announced the initiation of enrollment of its Phase III registration clinical study for M-Vax, its AC Vaccine® product candidate for the treatment of patients with Metastatic Melanoma. The trial will examine survival and response rate as measured by modified response evaluation criteria in solid tumors (modified RECIST criteria) in Stage IV melanoma patients with soft tissue or lung metastasis. The Phase III registration trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for M-Vax and in agreement with the FDA the company will be eligible to file for accelerated approval of M-Vax based upon achieving a response rate endpoint. The double blind, randomized trial is expected to enroll up to 387 patients to be completed over a period of 24 months. Patients will be randomized on a two to one basis to the treatment arm or control arm, respectively. The treatment arm consists of M-Vax followed by a regimen of low dose IL-2®; the control arm consists of placebo vaccine followed by low dose IL-2. Both treatment and control arms include BCG and low dose cyclophosphamide.

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