Exhibit 99.1
VaxGen Announces Results of its
Phase III HIV Vaccine Trial in Thailand: Vaccine Fails
to Meet Endpoints
BRISBANE, Calif. - November 12, 2003 - VaxGen, Inc. (Nasdaq: VXGN) today
announced preliminary results from its randomized, double-blind,
placebo-controlled Phase III clinical trial in Thailand to evaluate AIDSVAX B/E,
an investigational vaccine (rgp 120) for the prevention of HIV infection.
The vaccine candidate did not show efficacy for either the primary or
secondary endpoints. The primary endpoint for the trial was the prevention of
infection by HIV, the virus that causes AIDS. The secondary endpoints concerned
whether vaccination slowed the progression of disease among those who received
the vaccine but later became infected with HIV. The vaccine candidate appeared
to be well tolerated with no serious adverse events related to the vaccine. The
vaccine cannot cause HIV infection.
The trial was well conducted in accordance with international good
clinical practices. Extensive education and risk-reduction counseling were
provided during the trial. Data indicate that study volunteers reported marked
reductions in behaviors, including sharing of needles, associated with HIV
infection.
"This trial was conducted according to the highest international clinical
standards, and is one of many examples of Thailand's long-standing commitment to
HIV vaccine development," said Kachit Choopanya, M.D., the trial's principal
investigator. "With the help of the trial volunteers and national and
international collaborators, Thailand has strengthened its research capacity and
acquired valuable expertise with which to carry on clinical research."
The trial results were analyzed by scientists from the Bangkok Vaccine
Evaluation Group (BVEG), the U.S. Centers for Disease Control and Prevention
(CDC), the Statistical Center for HIV/AIDS Research and Prevention (SCHARP) of
the Fred Hutchinson Cancer Research Center, and VaxGen.
"The outcome of this trial is one more reminder of how difficult it is to
combat HIV and how important it is for the international public health community
to redouble the effort to develop an effective vaccine," said Donald P. Francis,
M.D., D.Sc., VaxGen's president. "Although we are disappointed with the outcome,
VaxGen and our Thai collaborators have created a model that can be used around
the world for advanced clinical research of an HIV vaccine."
About the Phase III Clinical Trial of AIDSVAX B/E
The trial was designed to evaluate the safety and efficacy of AIDSVAX B/E,
primarily against the blood-borne transmission of HIV subtype E and one strain
of HIV subtype B. The study volunteers were 2,546 injecting drug users in
Bangkok, Thailand. During the 36-month trial, a total of seven injections were
administered at months 0, 1, 6, 12, 18, 24 and 30. The ratio of vaccine to
placebo recipients was 1:1.
During the trial, 105 volunteers who received placebo became infected with
HIV; 106 volunteers who received at least one injection of AIDSVAX B/E became
infected. The annualized infection rate in placebo and vaccine recipients was
3.1%.
The trial was conducted at 17 clinical sites in the greater Bangkok
Metropolitan Area. Trial volunteers received education and counseling every six
months to avoid behavior that could lead to HIV infection and were advised to
assume that they may have received a placebo or that the vaccine might be
ineffective.
"This was an international effort that brought together the public and
private sectors to focus on a common cause," Kachit said. "We owe a special debt
to the people who stepped forward to volunteer for this trial. More than 90% of
the volunteers completed their full three-year commitment to the study, and
their dedication should serve as an inspiration for others to volunteer for HIV
vaccine studies."
The trial design was reviewed by the Thailand Food and Drug
Administration, the Thailand Ministry of Public Health (MOPH), the Thailand
National AIDS Subcommittee on AIDS Vaccines, the Bangkok Metropolitan
Administration Ethical Review Committee, the Committee on Human Rights Related
to Human Experimentation, Mahidol University, the UNAIDS Vaccine Advisory
Committee, the U.S. FDA and its Vaccine Advisory Committee, and the
Institutional Review Board of the CDC. The study was primarily funded and
overseen by VaxGen and administered by BVEG, a partnership among the Bangkok
Metropolitan Administration, Mahidol University, the Thailand MOPH-U.S. CDC
Collaboration and VaxGen.
About VaxGen
Based in Brisbane, Calif., VaxGen is a biopharmaceutical company engaged
in the development, manufacture and commercialization of biologic products for
the prevention and treatment of serious human infectious disease, including
anthrax and smallpox. For more information, please visit the company's website
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 VaxGen's plans regarding the future
development of any HIV vaccines. 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 August 18, 2003,
under the heading "Risk Factors", and the company's Annual Report on Form 10-K,
filed with
the Securities and Exchange Commission on March 31, 2003, 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.
Contact:
Lance Ignon
Vice President
Corporate Communications
(650) 624-1041