BioSante Pharmaceuticals Presents New Anthrax Vaccine Data at World Vaccine Congress
March 22 2006 - 7:00AM
Business Wire
BioSante Pharmaceuticals, Inc. (Amex:BPA) today will present new
positive study results toward the development of a
second-generation anthrax vaccine at the annual World Vaccine
Congress here. BioSante is developing the anthrax vaccine for the
U.S. Department of Defense under a subcontract with DynPort Vaccine
Company. Dr. Steve Bell, vice president of research and
pre-clinical development for BioSante, will present the new
findings in a case study report on the ongoing research and
development of a next generation needle-free anthrax (rPA) vaccine
using BioVant(TM), the company's patented calcium phosphate (CaP)
nanoparticulate technology. Dr. Bell will review previously
announced studies confirming that rPA-specific immunogenicity
results with BioVant in mice also held true in rabbits. Following
intranasal administration of the BioVant non-injection anthrax
vaccine candidate in both animal models, high levels of
anthrax-specific systemic antibodies occurred with good duration of
immunity. Also, adding BioVant to the mucosally (intranasally)
delivered vaccine candidate, may allow for the use of less anthrax
antigen per vaccine dose, an important consideration for vaccines
in short supply. Dr. Bell also will present new data showing that
the BioVant/anthrax vaccine candidate can be delivered
transcutaneously using select needle-free devices, and that
antibody responses were the same as those of needle injections.
Needle-free devices have been earmarked for rapid mass
immunizations, for example, of military personnel whose tour of
duty takes them to bioterror risk areas. Further, in addition to
BioVant's potential to use less antigen per dose, its ability to be
stored as a dry powder, possibly extending storage periods may make
it a more attractive product to governments seeking to maximize the
value of strategic anthrax vaccine stockpiles. Dr. Bell will note
that these developments highlight the potential for alternative
needle-free modes for the administration of second-generation
anthrax vaccines. "These results further indicate BioVant's
potential as a safer, next-generation alternative to injectable
alum, currently the only FDA-approved adjuvant," said Stephen M.
Simes, president and chief executive officer of BioSante. "We are
pleased with these findings and remain dedicated to the continued
development of BioVant under our subcontract with DynPort Vaccine
Company for the U.S. Department of Defense, as well as other CaP
development activities for improved vaccines and protein and
peptide delivery." For additional information on the World Vaccine
Conference, visit http://www.lifescienceworld.com/2005/wvcm_CA/.
About BioVant Formulated using BioSante's proprietary CaP
nanotechnology, BioVant is being tested as an adjuvant for
non-injected anthrax vaccines. While injectable aluminum salt
(alum) derivatives are the only vaccine adjuvants approved by the
FDA, they have been associated with adverse reactions including
irritation and inflammation of the injection site, and are not a
candidate for non-injection administration of vaccines. Composed of
specially formulated calcium phosphate, BioVant has not been shown
to cause inflammation or allergic reaction after administration and
may be used by non-injected routes of administration BioSante is
developing BioVant under a subcontract with DynPort in support of
the U.S. Department of Defense Joint Vaccine Acquisition Program
(JVAP). BioSante is investigating additional vaccine development
funding under Project BioShield for anthrax, as well as other
biodefense risks. 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(TM)
(transdermal estradiol gel) for the treatment of women with
menopausal symptoms, and LibiGel(TM) (transdermal testosterone gel)
for the treatment of female sexual dysfunction (FSD). A Bio-E-Gel
new drug application (NDA) was submitted to the FDA on February 16,
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 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 press release that are not historical in
nature, particularly those that utilize terminology such as "may,"
"will," "should," "likely," "expects," "anticipates," "estimates,"
"believes" or "plans,""hopes", or comparable terminology, are
forward-looking statements. Examples of forward-looking statements
in this release include the statement regarding CaP being a safer,
next-generation alternative to injectable alum salt derivatives,
currently the only FDA-approved adjuvants. 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 of BioSante's most recent Form 10-Q,
which discussion also is incorporated herein by reference. 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.
Biosante Pharma (AMEX:BPA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Biosante Pharma (AMEX:BPA)
Historical Stock Chart
From Jul 2023 to Jul 2024