Biosante Pharma (AMEX:BPA)
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BioSante Pharmaceuticals, Inc. (Amex:BPA) today
announced that it will present positive results of several
pre-clinical studies, demonstrating that its calcium phosphate (CaP)
nanoparticle-based vaccine adjuvant, BioVant(TM), may serve as an
adjuvant for the development of an effective flu virus vaccine,
including the potentially pandemic H5N1 bird flu. Dr. Steve Bell, vice
president of research and pre-clinical development at BioSante, will
present today at the 9th Annual Conference on Vaccine Research in
Baltimore.
"As the potential danger of a bird flu pandemic rises, the need
for a safe and effective vaccine grows increasingly urgent," 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 prevent shortages. More
importantly, addition of an adjuvant may enable more people to produce
an immune response that would offer protection from disease."
BioSante will present the positive results of three
BioVant-adjuvanted flu vaccine pre-clinical studies using the M1
protein, H3N1, and H5N1 (known as bird flu) virus strains. These
vaccine candidates were delivered via injection and non-injection
(needle-free). The cumulative results confirm that:
-- BioVant can enhance flu-specific immunity
-- BioVant - M1 Protein Flu vaccine protected animals from live
H1N1 flu virus
-- BioVant elicits high titers of bird flu-specific antibodies
(1:6,400)
-- BioVant may be a good mucosal adjuvant for the H5N1 vaccine.
Adjuvanted bird flu vaccines have increased in importance due to a
paper published in a recent issue of the New England Journal of
Medicine. The paper reported that an experimental, non-adjuvanted bird
flu vaccine, currently under development by the U.S. government and a
European drug company, is only effective at high doses and that only
54 percent of subjects produced the desired immune response.
The new results from ongoing studies with the H5N1 bird flu
antigen indicate that BioVant can significantly enhance anti-bird flu
immunity (titers 1:6,400) after injection or after intranasal
(needle-free) administration with low doses (2.5 micrograms) of H5N1
antigen.
"These BioVant adjuvant study results suggest that we may be able
to develop flu vaccines that use less flu antigen to attain adequate
immune protection against a potentially deadly bird flu virus," said
Dr. Bell. He will also highlight the new results showing that the
BioVant-H5N1 vaccine candidate appears to work well after intranasal
administration.
About Avian (or Bird) Flu and BioVant(TM)
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 can be transmitted from birds to
humans, and has infected 196 people and killed 110 since the beginning
of 2005. 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 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.
While aluminum salt derivatives such as alum are the only adjuvants
currently approved by the FDA, alum has been associated with adverse
reactions such as irritation and inflammation at the injection site,
and may exacerbate allergy.
In contrast, BioVant is composed of specially formulated calcium
phosphate (CaP), 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, and has
been shown to both prevent the manifestation of allergy, and, to
effectively 'switch off' established Th2-T-cell-associated allergic
disease.
"We believe BioVant shows potential to be an important
non-injectable delivery system and adjuvant for the next generation of
vaccines against both viral and bacterial infections," Simes said. "In
addition to the avian flu vaccine, BioSante and several commercial and
military partners are now conducting additional pre-clinical studies
of BioVant in several potential vaccines, and we are pursuing
additional collaborations and licenses for further development of
CaP."
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
Bio-E-Gel(R) (transdermal estradiol gel) for the treatment of women
with menopausal symptoms, and LibiGel(R) (transdermal testosterone
gel) for the treatment of female sexual dysfunction (FSD). A Bio-E-Gel
new drug application (NDA) was submitted to the FDA in the first
quarter 2006. 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 Inc. The company also is developing its
calcium phosphate nanotechnology (CaP) for novel vaccines, including
avian flu and biodefense vaccines for toxins such as anthrax and
ricin, 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 CaP will not prove to be
an effective vaccine adjuvant and that vaccine development is very
long term and very expensive. 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.