Company crows
about government backing for VaxGen's
AidsVax clinical trial
The
failure of AidsVax to prevent infection
with HIV - in clinical trial results
published in 2003 - triggered an intense
debate about the controversial product
and its manufacturer, VaxGen Inc of
Brisbane, California. Mail to this
website, maintained by Brian Deer, shows that
existing material on a VaxGen-AidsVax
index is read by significant
numbers. This page seeks to further
inform the discussion
VaxGen's
stock price soared in the quarter
following the press release below, which
many investors took to imply government
endorsement of the company's product.
Also on this page is an extract from a
May 2001 SEC filing, indicating that
although the $8m was not paid directly to
the company, it covered clinical trial
costs that would otherwise have been
incurred by VaxGen. On February 24 2003,
it was announced that the trial had
failed to show efficacy for AidsVax.
In
VaxGen's initial public offering
prospectus, dated June 1999, the company
tells investors (page 20): "We
anticipate receiving an aggregate of
approximately $12,600,000 from the
Centers for Disease Control and
Prevention and the National Institutes
for Allergy and Infectious Diseases
commencing in September 1999. We believe
these funds will enable us to meet
anticipated operating expenditures for an
additional year." By October 1999,
following the publication of Deer's
report, the story had changed somewhat,
as the press release below suggests.
Centers for
Disease Control Joins VaxGen Study;
Awards $8 Million Contract to
Supplement HIV Vaccine Research
PRNewswire
- October 29, 1999
BRISBANE,
Calif., Oct. 29 /PRNewswire/ VaxGen
Inc. (Nasdaq: VXGN) today announced
that the federal Centers for Disease
Control and Prevention (CDC) will
contribute funds to support
additional research at five of the 56
clinics in the United States
currently conducting Phase III
clinical trials of VaxGen's AIDSVAX
vaccine.
The
CDC will contribute $2 million
annually, for four years, to the
selected clinics. The focus of the
additional research supported by the
contract is "to answer critical
questions about how this and future
vaccine trials may impact the
attitudes and behaviors of both trial
participants and the communities
involved," according to the CDC.
"The
CDC's support of our trial opens key
avenues towards achieving our goals
of ending the AIDS epidemic,"
said Dr. Donald P. Francis, president
of VaxGen. "VaxGen will benefit
from the vast experience of CDC, the
U.S. government's premier HIV
prevention organization. In turn, we
will be sharing data and data
analysis with the CDC."
The
five clinical sites that will receive
the CDC funds are San Francisco
Department of Public Health, Fenway
Community Health Center in Boston,
Ohio State University, Howard Brown
Health Center in Chicago, and the
University of Washington in Seattle.
The contract calls for CDC to assume
clinical expenses for trial
volunteers at these sites. Each
participating site will continue to
implement VaxGen's Phase III
protocol, as well as conduct the
additional research.
May 03, 2001
VAXGEN INC
(VXGN)
Quarterly Report
(SEC form 10-Q)
Excerpt:
"In
October 1999, we entered into a
collaboration with the federal
Centers for Disease Control and
Prevention ("CDC") to
support research at six of the 56
clinics in the United States
currently conducting Phase III
clinical trials of our AIDSVAX(R)
vaccine. The CDC selected the six
sites in the fourth quarter of 1999.
Contractual arrangements between the
CDC and the clinics were completed in
the second quarter of 2000. The
participating sites will continue to
implement our Phase III protocol, as
well as conduct epidemiological,
social and behavioral research, which
will be shared by the Company and the
CDC. The sites will be compensated
directly by the CDC for the clinical
costs, which would have been incurred
by the Company, and for conducting
the additional research. The CDC has
agreed to contribute approximately
$8,000,000 to the participating sites
over a four-year period."
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