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BioSante Pharmaceuticals, Inc. (Amex: BPA) today announced a presentation of flu vaccine data entitled, "Calcium Phosphate (CaP) Nanoparticles as a Candidate Adjuvant for Influenza/Avian Influenza Vaccine" at the annual Novel Vaccines Conference in Cambridge, MA on August 23rd and 24th.
The data described BioSante's progress towards the development of adjuvanted seasonal influenza and pandemic H5N1/bird flu vaccines. Presented are data from several preclinical studies, including a challenge study and a preclinical bird flu study with promising Hemagglutinin Inhibition Assay titer results.
"We are working to create an adjuvant that will allow for the use of lower-dose vaccines yet still confer a higher level of immunity than currently approved vaccines," said Dr. Tulin Morcol, BioSante's director of vaccine development and protein delivery. "The results presented at this meeting confirm that a vaccine combined with BioVant™, BioSante's patented CaP vaccine adjuvant, may improve immunity and stretch potentially limited vaccine supplies allowing for a greater number of people to receive the vaccines."
Earlier this year, BioSante reported results based on a study using a hemagglutination inhibition assay (HAI), which showed the clear adjuvanting effect of BioVant. After a prime and one booster of BioVant-H5N1-combination-vaccine, the immune response in a rodent model was four-fold that of the H5N1 antigen alone. The study was done with 3 micrograms of H5N1 antigen in each vaccine dose which we believe may lead to a lower dose human vaccine. The only FDA approved H5N1/bird flu vaccine uses 90 micrograms of H5N1 antigen by itself given in each of two doses.
"These results further indicate BioVant's potential as a safer, next-generation alternative to injectable aluminum salts, currently the only FDA-approved adjuvants," 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 both internally as well as with current and potential collaborators for improved vaccines, protein delivery and for aesthetic medicine."
BioSante's preclinical study objective was to determine whether BioVant could enhance the body's natural immune response to the annual human flu viruses and the avian subtype H5N1 viral antigen, the cause of bird flu. At the start of the study, mice received either the flu 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 avian flu-specific antibodies which were significantly higher than that of H5N1 alone. Anti-avian flu antibody levels continued to increase over the entire study period, suggesting good duration of immunity.
An adjuvant is a substance that, when added to a vaccine, enhances the vaccine's effectiveness by enhancing the body's immune response. 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 allergic response, and, to effectively ‘switch off' established Th2-T-cell-associated allergic reactions.
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 bio-identical estradiol and testosterone. BioSante's lead products include Elestrin™ (estradiol gel) developed through FDA approval by BioSante indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, marketed in the U.S. by Bradley Pharmaceuticals, Inc., BioSante's licensee, and LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante for the treatment of female sexual dysfunction (FSD). Also in development is Bio-T-Gel™, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3.0 billion. The company also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, including hepatitis B, avian flu and biodefense vaccines for toxins such as anthrax, as well as a system for delivering drugs via alternative routes of administration and for aesthetic medicine.
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,” “would,” “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 could cause actual results to differ materially from those expressed in such forward-looking statements include the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, the success of clinical testing, and other factors identified and discussed from time to time in BioSante's filings with the Securities and Exchange Commission, including those factors discussed in BioSante's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q, which discussions also are 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.
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BioSante Pharmaceuticals, Inc.
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