Avax initiates Phase III registration trial for metastasis vaccine

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.

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 FDA for M-Vax. 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 study is expected to include up to 50 centers in the US, Europe and Israel. Dependant on the rate of enrollment of the centers, rate of disease progression in the patients and the number of responses seen, an interim analysis is targeted for 2009 and, if successful, could serve as the basis for submitting for product approval in accordance with the accelerated approval regulations and SPA agreement with the FDA.

David Berd, chief medical officer of Avax, said: “We have previously demonstrated in clinical trials with M-Vax in metastatic melanoma patients a significant level of immune response activity in patients tumors that was not present prior to treatment, sometimes culminating in complete or partial tumor responses. With the potential additive benefit of IL-2 on strengthening the T-cell based immune response induced by M-Vax, we have designed a compelling study to demonstrate the positive adjuvant effects of M-Vax on response rate and survival in patients.”