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Press Release
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Apthera Announces Completion of End of Phase II Meeting with the U.S. Food and Drug Administration for NeuVax™ for Breast Cancer
Company Finalizing Protocols for Phase II/III Registration Study
Scottsdale, Arizona, Oct. 30, 2007 - 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.
Contact Apthera:
Gail Thurston
VP, Corporate and Business Development
(480) 882-8841
business@apthera.com
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