Healthcare Industry News: HER2
News Release - January 22, 2008
Apthera Files a Phase III Special Protocol Assessment with FDA for NeuVax(TM) in Early-Stage Breast Cancer PatientsSCOTTSDALE, Ariz.--(HSMN NewsFeed)--Apthera, Inc. announced today that it 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 (“SPA”). 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.
Dr. Joseph Sinkule, Chairman and Founder of 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 & 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. For more information about the Company visit www.apthera.com.
NeuVax is a HER2/neu peptide-based T-cell immunotherapy aimed at preventing disease recurrence and prolonging survival in cancer patients that have tumors 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.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are not historical facts and are subject to risks and uncertainties which could cause actual results and the timing of certain events to differ materially from those set forth in or implied herein including, without limitation, risks associated with clinical development, regulatory approvals, product commercialization, intellectual property claims litigation and other risks associated with the Company’s proposed activities.
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