BioSante Pharmaceuticals Announces Positive Study Results for Potential Adjuvanted Bird Flu Vaccine
April 24 2006 - 7:00AM
Business Wire
BioSante Pharmaceuticals, Inc. (AMEX:BPA) today announced positive
results of a new study demonstrating that its calcium phosphate
(CaP) nanoparticle-based vaccine adjuvant, BioVant(TM), may serve
as a vaccine adjuvant for the development of an effective vaccine
against H5N1 avian flu, widely known as bird flu. "As the potential
danger of a pandemic rises, the need for a safe and effective bird
flu 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 to prevent shortages. More
importantly, addition of an adjuvant may enable more people to
produce an immune response to protect them from disease." Addition
of a vaccine adjuvant has increased in importance due to a paper
published in a recent issue of the New England Journal of Medicine.
It was reported that an experimental bird-flu vaccine under
development by the U.S. government and a European drug company
without an adjuvant is effective only at high doses and that only
54 percent of subjects produced the desired immune response.
BioSante's preclinical study's 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
10-week 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, and significantly higher than H5N1 alone.
Anti-avian flu antibody levels continued to increase over the
entire study period, suggesting good duration of immunity. "These
new H5N1 plus BioVant adjuvant study results may represent an
important advance toward protecting the human population against a
potentially deadly virus," said Dr. Steve Bell, vice president of
research and preclinical development at BioSante. He noted that the
demonstrated effectiveness of BioVant may also permit a reduction
in the needed dosage of H5N1 antigen, which is currently in limited
supply. Dr. Bell will present BioSante's avian flu data on May 8,
2006 at the Ninth Annual Conference on Vaccine Research in
Baltimore, Maryland. 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 has
already made the jump from birds to humans and in fact, has
infected 186 people and killed 108 over the past two to three
years. 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
CaP, in the form of BioVant, shows potential to be an important
non-injection 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
the company is 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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