BioSante Pharmaceuticals Announces Positive Bird Flu Results Using Proprietary Vaccine Adjuvant in Pre-Clinical Study
January 30 2007 - 8:00AM
Business Wire
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.
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