BioSante Pharmaceuticals to Present Positive Study Results for Potential Adjuvanted Bird Flu Vaccine at 9th Annual Conference o
May 08 2006 - 7:00AM
Business Wire
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.
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