For registration of its lead cancer therapeutic, NeuVax, Apthera, Inc. submitted a phase III clinical protocol and statistical analysis plan to the FDA for review under a Special Protocol Assessment (SPA). The international phase III randomised, 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.
NeuVax is a HER2/neu peptide-based T-cell immunotherapy aimed at preventing disease recurrence and prolonging survival in cancer patients that have tumours expressing the HER2/neu oncoprotein. To date, clinical study results have demonstrated that NeuVax significantly reduces the rate of cancer recurrence while showing minimal side effects.
Dr. Joseph Sinkule, chairman and founder, Apthera commented, "the SPA provides the opportunity for the FDA to review and comment on Apthera's pivotal phase III study design, endpoints, and analysis plan before the clinical trial begins. 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."
Dr. Charles Morgan, president and CEO said, "Filing of the SPA represents not only a key product milestone but a verification of the Company's strategy for increasing shareholder value by acquiring late stage product candidates from its partners and completing key clinical/regulatory milestones.
Apthera, Inc. is developing a pipeline of peptide-based immunotherapies for cancers that express HER2/neu, a well-validated and established oncology target. Apthera is privately held with headquarters in Scottsdale, Arizona.