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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: http://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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BioSante Pharmaceuticals, Inc.
Phillip Donenberg, 847-478-0500
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