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Apthera has received a Special Protocol Assessment from the FDA for the Phase III trial of NeuVax in early-stage breast cancer

Apthera, Inc. announced recently that it had reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the planned Phase III clinical trial of Apthera’s lead drug, NeuVax.

The SPA is a written agreement between the trial’s sponsor and the FDA regarding the design, endpoints and planned statistical analysis of the Phase III trial to be used in support of a Biologics License Application. The SPA approval letter was received from the FDA on June 19, 2009, concluding a 21-month reiterative process between Apthera, the breast oncology community in the US and the Agency.

The multicenter, double-blind, randomized trial is expected to enroll 700 women diagnosed with HER2/neu-expressing tumours who have completed standard of care consisting of surgery, chemotherapy and radiotherapy. Women must have a common HLA haplotype (HLA-A2 or -A3) and must agree to be followed for 5–10 years. The primary endpoint of the study is disease-free survival, as determined by the lack of disease recurrence or death from any cause, and the first analysis of the data will occur after 70 recurrence events or approximately three years from the start of the study.

Alton C. Morgan, Ph.D., President and CEO, stated, ‘The positive outcome of the SPA process means Apthera has reached a major developmental milestone for NeuVax. With regulatory approval of the design of the pivotal trial, this achievement has created a value inflection milestone for both the product and the Company’.

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