BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
July 11 2007 - 8:00AM
Business Wire
BioSante Pharmaceuticals, Inc. (Amex: BPA) today announced new
positive results demonstrating that�its calcium phosphate (CaP)
nanoparticle-based vaccine adjuvant, BioVant�, may serve as an
effective vaccine adjuvant for the development of a dose sparing
vaccine against H5N1 avian flu, widely known as bird flu. The new
results are based on a study using a hemagglutination inhibition
assay (HAI), which showed the clear adjuvanting effect of BioVant.
After a prime and one booster of BioVant-H5N1-combination-vaccine,
the immune response in a rodent model was four-fold that of the
H5N1 antigen alone. The study was done with 3 micrograms of H5N1
antigen in each vaccine dose. Earlier this year, the U.S. Food and
Drug Administration approved an H5N1 vaccine that uses 90
micrograms of H5N1 antigen by itself given in each of two doses.
�We are working to create a vaccine using our BioVant that would be
given at lower doses per injection yet still confer a higher level
of immunity than the currently approved vaccine," said Stephen M.
Simes, president and chief executive officer of BioSante. "These
HAI study results confirm the BioVant antibody results previously
reported and add to the data base for a potential BioSante improved
BioVant adjuvanted bird flu vaccine.� �According to a paper
published in the New England Journal of Medicine, the currently
approved bird-flu vaccine without an adjuvant by a European drug
company is effective only at high doses (90 micrograms per dose)
and only 54 percent of subjects produced the desired immune
response. We believe a BioVant-adjuvanted H5N1 vaccine may use less
antigen per dose and protect a higher percentage of the
population." Mr. Simes continued. BioSante�s preclinical study
objective was to determine whether BioVant could enhance the body's
natural immune response to the H5N1 viral antigen, the cause of
bird flu. At the start of the trial, mice received either the H5N1
antigen alone or in a formulation with BioVant. A booster
immunization was administered after two weeks. Results indicated
that the administration of a BioVant-H5N1 formulation stimulated
production of high titers of H5N1-specific antibodies, which were
significantly higher than H5N1 alone. Anti-avian flu antibody
levels continued to increase over the entire study period,
suggesting good duration of immunity. Avian flu refers to a large
group of different influenza viruses that primarily affect birds.
While the vast majority of these viruses do not affect humans, the
H5N1 strain already has made the jump from birds to humans and in
fact, has infected 310 people and killed 190 since the outbreak of
the disease in 2003, and more than 250 million chickens have been
killed to stop the spread of the virus. Farmers and poultry
producers already have suffered losses in the billions of dollars.
There is widespread concern that a strain of avian flu will mutate
into a new form that is contagious among humans. Since there is
currently no truly effective vaccine available to protect humans
from H5N1 and humans do not have antibodies to fight this new virus
strain, there is significant risk of a pandemic. An adjuvant is a
substance that, when added to a vaccine, enhances the vaccine's
effectiveness by stimulating an immune system response. In multiple
studies, BioVant has been shown to be safe and cause minimal
dose-dependent inflammation at the injection site, and has been
shown to both prevent the manifestation of allergic response, and,
to effectively �switch off� established Th2-T-cell-associated
allergic disease. About BioSante Pharmaceuticals, Inc. BioSante is
developing a pipeline of hormone therapy products to treat both men
and women. These hormone therapy products are gel formulations for
transdermal administration that deliver bio-identical estradiol and
testosterone. BioSante's lead products include Elestrin� (estradiol
gel) developed through FDA approval by BioSante indicated for the
treatment of moderate-to-severe vasomotor symptoms associated with
menopause, marketed in the U.S.�by Bradley Pharmaceuticals, Inc.,
BioSante's licensee, and LibiGel� (transdermal testosterone gel) in
Phase III development by BioSante for the treatment of female
sexual dysfunction (FSD). Also in development is Bio-T-Gel�, a
testosterone gel for male hypogonadism, and an oral contraceptive
using BioSante patented technology. The current market in the U.S.
for estrogen and testosterone products is approximately $2.5
billion and for oral contraceptives approximately $3.0 billion. The
company also is developing its calcium phosphate nanotechnology
(CaP) for novel vaccines, including hepatitis B, avian flu and
biodefense vaccines for toxins such as anthrax, as well as a system
for delivering drugs via alternative routes of administration.
Additional information is available online at
www.biosantepharma.com. This news release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. The statements regarding BioSante contained in
this news release that are not historical in nature, particularly
those that utilize terminology such as �may,� �will,� �should,�
�would,� �likely,� �expects,� �anticipates,� �estimates,�
�believes,� �plans,� �hopes,� or comparable terminology, are
forward-looking statements. Forward-looking statements are based on
current expectations and assumptions, and entail various risks and
uncertainties that could cause actual results to differ materially
from those expressed in such forward-looking statements. Important
factors known to BioSante that could cause actual results to differ
materially from those expressed in such forward-looking statements
include the difficulty of developing pharmaceutical products,
obtaining regulatory and other approvals and achieving market
acceptance, the success of clinical testing, and other factors
identified and discussed from time to time in BioSante's filings
with the Securities and Exchange Commission, including those
factors discussed in BioSante's most recent annual report on Form
10-K and subsequent quarterly reports on Form 10-Q, which
discussions also are incorporated herein by reference. All
forward-looking statements speak only as of the date of this news
release. BioSante undertakes no obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise.
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