Exhibit 99.1
FDA Clears VaxGen's IND for an Attenuated Smallpox Vaccine Candidate
BRISBANE, Calif. - September 7, 2004 - VaxGen, Inc. (VXGN.PK) announced
today that the U.S. Food and Drug Administration (FDA) has cleared an
Investigational New Drug (IND) application for the company's candidate smallpox
vaccine, LC16m8.
The effective IND will allow VaxGen to begin clinical development of
LC16m8 with the objective of meeting the U.S. government's stated interest in
acquiring an emergency stockpile of an attenuated smallpox vaccine(1) and
licensing the product for commercial sales. The U.S. government has indicated
that it anticipates spending $1.9 billion to establish and maintain a stockpile
of attenuated smallpox vaccine over a 10-year period.
The IND clears the way for a Phase I/II human clinical trial to evaluate
the safety and immunogenicity of LC16m8 and compare it to Dryvax(R), the
smallpox vaccine currently licensed for use in the United States. The trial is
expected to begin before the end of this year. It will involve approximately 150
volunteers at four leading medical centers: Saint Louis University Health
Sciences Center, Stanford University, University of Kentucky and Vanderbilt
University Medical Center.
"LC16m8 was extensively evaluated during its development in Japan and has
a strong track record of safety," said Lance K. Gordon, Ph.D., VaxGen's
president and chief executive officer. "The clinical trial we plan to initiate
is part of the process required by the FDA to license LC16m8 for use in the
United States. We believe this trial also will provide the U.S. government and
other potential customers with important data to determine the best choice of
attenuated smallpox vaccines for their biodefense needs."
Achieving FDA approval for LC16m8 will depend on the results of current
and planned trials designed to satisfy FDA requirements for vaccine licensure.
About LC16m8
VaxGen is developing LC16m8 in the United States in partnership with the
Chemo-Sero-Therapeutic Research Institute (Kaketsuken) of Kumamoto, Japan. The
vaccine was initially developed in Japan to address the need for a smallpox
vaccine that was safer but as effective as conventional, unattenuated smallpox
vaccines. Studies involving approximately 50,000 children were conducted in
Japan, where the vaccine is currently licensed and manufactured commercially.
LC16m8 is produced in cell culture from vaccinia virus that has been
attenuated, or modified, to reduce its potential to cause unwanted side effects.
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(1) RFI No. ORDC-03-01: Large Scale Manufacturing Capabilities for Next
Generation Anthrax Vaccines e.g., Anthrax Recombinant Protective Antigen)
and Safer Attenuated Vaccinia Vaccines, August 2003.
LC16m8 has been shown to be less neurovirulent than unattenuated strains
of vaccinia in animal models(2). 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%
protection against poxvirus infection in both rabbits(3) and mice(4).
About the Phase I/II Clinical Trial of LC16m8
The 150 volunteers will be randomized 4:1, with 120 receiving LC16m8 and
30 receiving Dryvax. Study volunteers will be screened carefully for safety risk
factors prior to enrollment. The screening process includes a physician's
assessment of the volunteer's medical history, a physical exam, and a panel of
cardiac and laboratory tests. All study volunteers will continue to be evaluated
for safety in the clinic after vaccination and will return for regular safety
assessments throughout the study. No one will be exposed to smallpox as a part
of the clinical study.
About VaxGen, Inc.
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. Based in Brisbane, Calif., the company
is in the advanced stage of developing preventive vaccines against anthrax and
smallpox. VaxGen is the largest shareholder in Celltrion, Inc., a joint venture
formed to build operations for the manufacture of biopharmaceutical products.
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, the company's ability to win government contracts to supply
a smallpox vaccine, the timing, amount and scope of the any government award of
a contract for its purchase of a smallpox vaccine, the timing and results of any
clinical trials of LC16m8 or future development and commercialization
activities, and Kaketsuken's ability to continue manufacture of LC16m8. 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 1 of the company's Annual Report on Form 10-K filed by VaxGen on
March 30, 2004, under the heading "Additional Business Risks" 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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(2) S. Hashizume. The 39th Saburo Kojima Memorial Culture Prize: Development
of the Attenuated Smallpox Vaccine, LC16m8, Produced by Cell Culture. 28
Modern Media (Immunity). Vol. 50. No. 2. 2004.
(3) C. Empig, M. Merret-Gentil, T. Dermody, S. Isaacs, E. White, A. Rice, R.
Moyer. The Attenuated Vaccinia-Lister Vaccine LC16m8 Protects Rabbits from
Lethal Rabbitpox Challenge. National Foundation for Infectious Diseases
7th Annual Conference on Vaccine Research, May 26, 2004.
(4) C. Empig, J. Schriewer, R.M.L. Buller. The Attenuated Vaccinia-Lister
Vaccine LC16m8 Protects Mice from Aerosolized Ectromelia Challenge.
National Foundation for Infectious Diseases 7th Annual Conference on
Vaccine Research, May 26, 2004.
Contacts:
Kesinee Angkustsiri Yip
Associate Director, Corporate Communications
650-624-2304
Lance Ignon
Vice President, Corporate Affairs
650-624-1041
On Sept. 7: 650-238-4727