Apthera, Inc. has reached an agreement with the FDA under a Special Protocol Assessment (SPA) for its planned Phase III clinical trial of the company'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 (BLA).
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 U.S. and the Agency.
Chief Medical Officer, William E. Gannon, M.D., said, "We would like to thank FDA reviewers for their input and guidance during the SPA approval process and are pleased that the Agency has indicated an agreement to proceed with the Phase III protocol." The multicenter, double-blind, randomized pivotal trial is expected to enroll 700 women diagnosed with HER2/neu-expressing tumors and 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 (DFS) as determined by disease recurrence or death from any cause, and the first analysis of the data will occur after 70 recurrence events or approximately 3 years from the start of the study.
Alton C. Morgan, Ph.D., President and CEO, added, "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."