Apthera Announces Completion of End of Phase II Meeting with the U.S. Food and Drug Administration for NeuVax(TM) for Breast Cancer.Company Finalizing Protocols for Phase II/III Registration Study SCOTTSDALE, Ariz. -- 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) 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 Charles Morgan is the name of:
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 Side effects Effects of a proposed project on other parts of the firm. . This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. and other risks associated with the Company's proposed activities. |
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