BRISBANE, Calif., Jan. 17 /PRNewswire-FirstCall/ -- VaxGen, Inc. announced today that five scientific abstracts related to its smallpox vaccine candidate, LC16m8, have been accepted to the February 15-18th, 2006 American Society of Microbiology (ASM) Biodefense Research Meeting in Washington, DC. Researchers will present clinical and pre-clinical data from studies entitled:
-- Safety and Immunogenicity of Attenuated Smallpox Vaccine, LC16m8: Results from a Phase 2 Study -- Clinical Evaluation of Attenuated Smallpox Vaccine LC16m8 in Japan -- Attenuated Smallpox Vaccine LC16m8 Protects Mice from High-Dose Lethal Intranasal Ectromelia Challenge Administered 10 and 50 days Post-Vaccination -- Safety and Efficacy Study of Attenuated Smallpox Vaccine LC16m8 in Animals -- Attenuated Smallpox Vaccine LC16m8 Protects Cynomolgus Monkeys from Lethal IV Monkeypox-Zaire Challenge
“The abstracts to be presented at the ASM conference represent the latest addition to a wide body of data that describe the safety and efficacy of LC16m8,” said Lance K. Gordon, Ph.D., VaxGen’s President and Chief Executive Officer. “We believe LC16m8 represents a safe and effective alternative to conventional smallpox vaccines which have been associated with serious cardiac and neurologic adverse events.”
About LC16m8
VaxGen is developing LC16m8 for use in the United States and elsewhere in partnership with the Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN) of Kumamoto, Japan, the licensed manufacturer of LC16m8. The vaccine was initially developed in Japan to address the need for a smallpox vaccine that was safer than but as effective as conventional, unattenuated smallpox vaccines. LC16m8 is administered as a single dose at the surface of the skin, not by injection. Studies involving approximately 50,000 children were conducted in Japan, where the vaccine is currently licensed and manufactured commercially.
LC16m8 is a cloned virus vaccine produced in cell culture that has been shown to be less neurovirulent than unattenuated strains of vaccinia in preclinical models. Additionally, studies presented at the 7th Annual Conference on Vaccine Research sponsored by the National Foundation for Infectious Diseases in May 2004 demonstrated that LC16m8 provided 100 percent protection against poxvirus infection in both rabbits and mice.
About KAKETSUKEN
KAKETSUKEN is a Juridical Foundation which researches, develops, manufactures and supplies biological products such as vaccines for humans and animals, and blood plasma derivatives. Based in Kumamoto, Japan, the foundation has pursued the preventive medicine fields of microbiology, immunology and serology, towards the improvement of health and hygiene, and is a leading company in the fields of human vaccines, animal vaccines, and blood plasma derivatives respectively in Japan. For further information about KAKETSUKEN, please visit the company’s web site at http://www.kaketsuken.or.jp/index.html.
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, smallpox and Meningitis B. The company has been awarded an $877.5 million U.S. government contract to provide 75 million doses of its recombinant anthrax vaccine for civilian biodefense. Based in South San Francisco, Calif., VaxGen operates a wholly owned manufacturing facility in California and is a shareholder in Celltrion, Inc., a South Korean joint venture established to provide contract manufacturing to the global pharmaceutical industry. For more information, please visit the company’s web site at: http://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 potential safety and efficacy of LC16m8. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. 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 March 31, 2005, 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.
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CONTACT: Press, Paul Laland, Vice President, Public Affairs,+1-650-624-1041, or Investors and Financial Analysts, Lance Ignon, VicePresident, Corporate Affairs, +1-650-624-1041, both of VaxGen, Inc.
Web site: http://www.vaxgen.com//
