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news.Apthera has submitted a Phase III clinical protocol and statistical analysis plan for registration of its lead cancer therapeutic, NeuVax to the FDA for review under a special protocol assessment.
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The international Phase III randomized, double-blind, placebo-controlled study will compare standard of care treatment (SoC) versus SoC plus NeuVax for the prevention of recurrence in early-stage, node-positive breast cancer patients.
Joseph Sinkule, chairman and founder of Apthera, said: “The SPA approval process will provide Apthera a clear understanding of what the FDA is looking for and should increase the likelihood of FDA product approval for NeuVax if we achieve the agreed-upon endpoints.”