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VaxGen is nearing completion of its Phase III trial in Thailand,
testing a formulation of AIDSVAX designed to protect against HIV
subtypes B and E, and expects to announce results of that trial in
the second half of 2003. Subtype E is prevalent in Southeast and East
Asia and the Central African Republic. Unlike the AIDSVAX B/B trial,
which tested the vaccine against sexual transmission of the virus,
the trial in Thailand is testing the vaccine against infection
acquired by injection drug use.
VaxGen is also in an early stage of developing a vaccine against
HIV subtype C, prevalent in Sub-Saharan Africa, India and China. The
company is committed to developing increasingly effective
formulations of AIDSVAX that target all HIV subtypes. AIDSVAX B/B
Trial Statistics
Number of volunteers to complete three immunisations: 5,009
Placebo recipients: 1,679
AIDSVAX B/B recipients: 3,330
White volunteers: 4,185
Hispanic volunteers: 326
Non-white volunteers (Black, Asian, Other): 498
Black volunteers: 314
Annual study infection rate 2.7%
Approximate Efficacy (after at least 3 primary doses)
All volunteers: 3.8% (p-value = 0.76; confidence interval: -23%
to 24%)
Non-white volunteers: 67% (p-value á 0.01; confidence interval: 30%
to 84%)
Black volunteers: 78% (p-value á 0.02; confidence interval: 29%
to 93%)
Conference Call and Webcast
VaxGen will host a conference call and webcast today, Monday,
February 24, 2003, at 9:00 a.m. EST (14:00 GMT) to discuss the
results of its Phase III AIDS Vaccine Trial. Participants are asked
to dial in 10 minutes before the start of the call. The following
phone numbers will provide access to the conference call, the replay
of which will be available through February 28, 2003. WHEN: Monday,
Feb. 24, 2003 9 a.m. EST (14:00 GMT) WHERE: Live Call: Domestic:
888-937-5291 International: +1 212-271-4646 No passcode required
Replay: Domestic: 800-428-6051 International: +1 973-709-2089
Passcode: 286715 The replay will be available for five business days
following the call. Webcast: Accessed via any one of three web sites:
www.vaxgen.com, www.kaisernetwork.org,
www.companyboardroom.com (insert Ticker: VXGN)
(http://www.companyboardroom.com/company....)
About VaxGen
VaxGen is focused on the commercial development of biologic
products for the prevention and treatment of human infectious
diseases and is currently developing vaccines against HIV/AIDS,
anthrax and smallpox. Additionally, VaxGen is the largest shareholder
of Celltrion, Inc., a joint venture created to provide large-scale
manufacturing services, principally for products produced in
mammalian cell culture, including AIDSVAX. VaxGen is located in
Brisbane, Calif. For more information, please visit the company"s web
site at: www.vaxgen.com. AIDSVAX(R) is a registered trademark of
VaxGen.
VaxGen was co-founded by Donald Francis, M.D., D.Sc., and Robert
Nowinski, Ph.D. Francis leads the clinical development of the
vaccine, and Dr. Nowinski, who retired from VaxGen in 2001, was the
company"s entrepreneur, financing the company at its origin and key
early stages. AIDSVAX was invented by Phillip Berman, Ph.D., head of
VaxGen"s research and development.
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
outcome of any further analysis of the clinical data from this
AIDSVAX trial, the timing and progress of completion of development
efforts for AIDSVAX, the need for additional clinical trials to
support licensure of AIDSVAX, the timing or ultimate outcome of FDA
approval of AIDSVAX in racial subgroups or more broadly, and the
timing and progress of the Company"s second Phase III clinical trial
in Thailand. 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 VaxGen"s Quarterly
Report on Form 10-Q, filed with the Securities and Exchange
Commission on November 14, 2002, under the heading "Risk Factors" and
to VaxGen"s Annual Report on Form 10-K, filed with the Securities and
Exchange Commission on April 1, 2002, under the heading "Business"
for a more detailed description of such factors. 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.
Source: VaxGen
Contact: VaxGen Media and Investor Relations, tel: +1 877 682
9436, (+1-877-6VAXGEN), or international, +1 202 266 3325; Photo:
NewsCom: http://www.newscom.com/cgi-bin/prnh/19991112/VAXGENLOGO; AP
Archive: http://photoarchive.ap.org; PRN Photo Desk, +1 888 776 6555,
or +1 212 782 2840; Web site: http://www.vaxgen.com
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