Apthera Files a Phase III Special Protocol Assessment with FDA for NeuVax(TM) in Early-Stage Breast Cancer Patients.SCOTTSDALE, Ariz. -- Apthera, Inc. announced today that it has submitted a Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA clinical protocol and statistical analysis plan for registration of its lead cancer therapeutic, NeuVax[TM] to the 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. for review under a Special Protocol Assessment ("SPA"). The international Phase III randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , 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 Looking for In the context of general equities, this describing a buy interest in which a dealer is asked to offer stock, often involving a capital commitment. Antithesis of in touch with. and should increase the likelihood of FDA product approval for NeuVax if we achieve the agreed-upon endpoints." Dr. Charles Morgan, President & CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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. About Apthera 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. 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 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 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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