Apthera, Inc. announced today the positive completion of an End of Phase II meeting held on August 29, 2007 with the U.S. Food and Drug Administration (FDA) regarding the Company's breast cancer therapy, NeuVax. Based on the meeting with the FDA, Apthera will submit a finalized clinical protocol to the FDA under a Special Protocol Assessment (SPA) and expects to start a Phase II/III registration trial in the first half of 2008.
Dr. Charles Morgan, President and CEO of Apthera, commented, "Important progress has been made in the development of NeuVax for breast cancer as we now work on the final stages of developing the Company's first product. We look forward to ultimately making NeuVax commercially available as a treatment option for breast cancer survivors."
About Apthera
Apthera, Inc. is developing a pipeline of peptide-based immunotherapies for cancers that express HER2/neu. Apthera is privately held with headquarters in Scottsdale, Arizona. For more information about the Company visit www.apthera.com.
About NeuVax
NeuVax is a HER2/neu peptide-based T-cell immunotherapy aimed at preventing disease recurrence and prolonging survival in cancer patients that have tumors which express 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.
