Biosante Pharma (AMEX:BPA)
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BioSante Pharmaceuticals, Inc. (Amex:BPA) today announced positive
results of a dose ranging pre-clinical study demonstrating that its
calcium phosphate (CaP) nanoparticle-based vaccine adjuvant, BioVant™,
may serve as a vaccine adjuvant for the development of an effective
vaccine against H5N1 avian flu, widely known as bird flu.
BioSante’s pre-clinical study's objective was
to determine the optimal formulation of BioVant with a very low dose of
H5N1 antigen. At the start of the 16-week pre-clinical trial, mice
received either the H5N1 antigen alone or in one of several formulations
with BioVant, as well as various control groups. A booster immunization
was administered after two and 10 weeks. Results showed that the
administration of a BioVant/H5N1 formulation stimulated a significantly
higher production of titers of H5N1-specific antibodies than H5N1 alone.
Further, the anti-bird flu antibody levels continued to increase over
the entire study period, suggesting good duration of immunity.
"Recent news suggests that bird flu has not gone away. We continue to
make progress in our adjuvanted H5N1 vaccine development," said Stephen
M. Simes, president and chief executive officer of BioSante. "A vaccine
with an adjuvant included may allow for better efficacy and lower doses
per vaccination which may help to prevent shortages. More importantly,
the addition of an adjuvant may enable a higher percentage of people
inoculated to produce an immune response and protect them from disease."
“Coupled with our previously announced results
using a BioVant adjuvanted H5N1 vaccine delivered intranasally, we
believe this dose ranging study further confirms the potential of
BioVant to be used as part of a dose sparing, easier to administer,
non-injected vaccine, which we believe could garner wider compliance in
initial and booster administration,” Simes
said. “We hope to move into additional
pre-clinical trials and attract a vaccine manufacturer to use BioVant in
a new flu vaccine."
Bird 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 has already made the jump from birds to
humans and in fact, has infected 270 people and killed 164 since
December 2003. There is widespread concern that a strain of bird flu
will mutate into a new form that is contagious among humans. Since there
is currently no 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.
BioVant is composed of specially formulated calcium phosphate, a
compound similar to that found in teeth and bones. In multiple studies,
BioVant has been shown to be safe and cause minimal dose-dependent
inflammation at the injection site. As opposed to the conventional
vaccine adjuvant alum, BioVant induces insignificant immunoglobulin E
(IgE) and higher serum IgG2a levels, a reaction that is widely
recognized as a precursor of a Th1 CD4 T-cell response. Th1-type
responses are known to promote immunity against intracellular pathogens.
"We believe CaP, in the form of BioVant, shows potential to be an
important adjuvant for the next generation of vaccines against both
viral and bacterial infections," Simes said. "In addition to the bird
flu vaccine, BioSante is pursuing additional collaborations and licenses
for further development of CaP in both vaccines and drug delivery."
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 bioidentical estradiol and
testosterone. BioSante's lead products include Elestrin™
(estradiol gel), FDA approved for the treatment of moderate-to-severe
vasomotor symptoms associated with menopause, and LibiGel®
(transdermal testosterone gel) in development for the treatment of
female sexual dysfunction (FSD). The current market in the U.S. for
estrogen and testosterone products is approximately $2.5 billion. The
transdermal gel formulations used in the women's gel products are
licensed by BioSante from Antares Pharma. BioSante also is developing
its calcium phosphate nanotechnology (CaP) for novel vaccines, including
bird flu and biodefense vaccines for toxins such as anthrax, and drug
delivery systems. 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," "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 cause actual results to differ
materially from those expressed in such forward-looking statements are
the difficulty of developing pharmaceutical products, obtaining
regulatory and other approvals and achieving market acceptance, and
other factors identified and discussed from time to time in BioSante's
filings with the Securities and Exchange Commission, including those
factors discussed on pages 22 to 34 in BioSante's most recent Form 10-K,
which discussion also is incorporated herein by reference. Additional
risk factors include the risk that BioVant will not prove to be an
effective vaccine adjuvant and that vaccine development is very long
term, expensive and risky. 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.