AVAX ANNOUNCES SPA AGREEMENT WITH FDA FOR CANCER VACCINE TRIAL

Avax Technologies has reached a Special Protocol Assessment (SPA) agreement with the FDA for the initiation of a Phase III clinical trial of M-Vax, the company's AC vaccine technology for the treatment of patients with metastatic melanoma. The SPA is a written agreement between AVAX and the FDA regarding the trial design, surrogate endpoints to be used as a basis of filing for accelerated approval of M-Vax and the statistical analysis plan necessary to support the full regulatory approval of M-Vax.

The Phase III study will enroll up to 387 patients with stage IV melanoma, who will be assigned in a double-blind fashion at a 2-1 ratio to M-Vax or placebo vaccine. The M-Vax arm will consist of an initial dose of M-Vax (autologous DNP-modified tumor cells) followed by cyclophosphamide and then six weekly doses of M-Vax administered with bacillus of calmette and guerin. Following vaccine administration patients will receive a specific schedule of low dose IL-2. Patients assigned to the control group will receive a treatment identical to the M-Vax group, except that a placebo vaccine will replace M-Vax. The primary endpoints of the study are best overall anti-tumor response rate and the percentage of patients surviving at least two years.

The data analysis plan for the study includes an interim analysis of best overall response rate (complete and partial) to be performed when half the patients (194 patients) have completed assessment of their best anti-tumor response. The comparison of the best overall response rates for the M-Vax and control groups will be used as the basis for an expected initial biologics license application submission under 21 CFR 601 Subpart E, which provides for accelerated approval using a surrogate endpoint in certain life-threatening diseases. The analysis of overall survival will be performed when patients have reached the two-year point.