Biosante Pharma (AMEX:BPA)
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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.