Biosante Pharma (AMEX:BPA)
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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.