BRISBANE, Calif., Aug. 14 /PRNewswire-FirstCall/ -- VaxGen, Inc. announced today that peer-reviewed data from the company's Phase I clinical trial of its candidate anthrax vaccine rPA102 were published in the journal Vaccine(1).
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The paper, titled "Immunogenicity and Tolerance of Ascending Doses of a Recombinant Protective Antigen (rPA102) Anthrax Vaccine: A Randomized, Double-blinded, Controlled, Multicenter Trial," presents data which demonstrated a clear relationship between the rPA102 dose administered and the subsequent immune response. All injections were administered four weeks apart and at each dose level examined, three injections of the vaccine candidate yielded higher antibody titers than with two injections. No clinically serious or dose-related toxicity was observed in this study.
"We need a better vaccine to help protect people from anthrax infection, whether the vaccine is given before or soon after exposure to anthrax spores," said Geoffrey J. Gorse, M.D., Professor of Internal Medicine, Saint Louis School of Medicine and lead author of the paper. "In this study we were able to demonstrate that the investigational anthrax vaccine produced an immune response that justifies further testing in larger studies. Data from this study will be used to help design strategies for testing this vaccine in the future."
Geoffrey J. Gorse, M.D., at the Saint Louis University School of Medicine, along with colleagues at Baylor College of Medicine, Emory University School of Medicine, Johns Hopkins University and VaxGen conducted the study.
The Phase I study was funded by VaxGen's contract N01-AI-25494 with the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH).
About rPA102
VaxGen's rPA102 vaccine candidate is a recombinant Protective Antigen (PA) protein vaccine that was initially developed by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). The vaccine candidate contains the protein, Protective Antigen, produced using recombinant technology from a strain of B. anthracis bacteria that is genetically modified to prevent the production of spores, toxins or virulence factors. rPA102 cannot cause anthrax infection.
About VaxGen
VaxGen, Inc. is a biopharmaceutical company engaged in the development, manufacture and commercialization of biologic products for the prevention and treatment of human infectious diseases, including anthrax and smallpox. VaxGen has been awarded an $877.5 million contract by the U.S. Department of Health and Human Services to provide 75 million doses of a modern anthrax vaccine for civilian biodefense. Based in Brisbane, Calif., VaxGen operates a wholly owned manufacturing facility in California and owns a minority interest in Celltrion, Inc., a company in the Republic of Korea established to provide contract manufacturing to the global pharmaceutical industry. For more information, please visit the company's web site at www.vaxgen.com.
Note: This press release contains "forward-looking statements" within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the progress and timing of the development of the company's investigational anthrax vaccine and its safety, tolerability and immunogenicity. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Item 8.01 of the company's Current Report on Form 8-K filed by VaxGen on February 16, 2006 under the heading "Risk Factors" for a more detailed description of such risks. Readers are cautioned not to place undue reliance on these forward- looking statements that speak only as of the date of this release. VaxGen undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
(1) Gorse, GJ, et al. 2006. Immunogenicity and Tolerance of Ascending Doses of a Recombinant Protective Antigen (rPA102) Anthrax Vaccine: a Randomized, Double-Blinded, Controlled, Multicenter Trial. Vaccine 24(33-34):5950-5959.
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