BioSante Pharmaceuticals Presents CaP-adjuvanted Bird Flu Vaccine Data at Vaccine Discovery and Commercialization Conference
Dr. Bell provided an in-depth review of data presented earlier this month from three BioVant-adjuvanted flu vaccine pre-clinical studies using the M1 protein, H3N1 and H5N1 antigens. Results showed that BioVant effectively delivered flu vaccines and, concurrently, enhanced the body's natural immune responses to flu virus antigens, including the potentially pandemic bird flu.
“BioVant may also permit a reduction in the needed dosage of influenza antigen, including the H5N1 antigen, which is currently in limited supply.”
The cumulative results confirm that:
-- BioVant can enhance flu-specific immunity
-- BioVant - M1 Protein Flu vaccine protected animals from live H1N1 flu virus
-- BioVant elicits high titers of bird flu-specific antibodies (1:6,400)
-- BioVant may be a good mucosal adjuvant for the H5N1 vaccine.
"These CaP-influenza vaccine results suggest we have good potential to develop an adjuvant-enhanced influenza vaccine," said Dr. Bell. "BioVant may also permit a reduction in the needed dosage of influenza antigen, including the H5N1 antigen, which is currently in limited supply."
During his presentation, Dr. Bell also discussed mode of delivery, number of doses, use of adjuvant, vaccine efficacy and safety, scale-up and manufacturing.
About Avian (or Bird) Flu and BioVant(TM)
Avian 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 can be transmitted from birds to humans, and has infected 196 people and killed 110 since the beginning of 2005. There is widespread concern that a strain of avian 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.
An adjuvant is a substance that, when added to a vaccine, enhances the vaccine's effectiveness by stimulating an immune system response. While aluminum salt derivatives such as alum are the only adjuvants currently approved by the FDA, alum has been associated with adverse reactions such as irritation and inflammation at the injection site, and may exacerbate allergy.
In contrast, BioVant is composed of specially formulated calcium phosphate (CaP), 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, and has been shown to both prevent the manifestation of allergy, and, to effectively 'switch off' established Th2-T-cell-associated allergic disease.
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(R) (transdermal estradiol gel) for the treatment of women with menopausal symptoms, and LibiGel(R) (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD). A Bio-E-Gel new drug application (NDA) was submitted to the FDA in the first quarter 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 avian flu and 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 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 CaP will not prove to be an effective vaccine adjuvant and that vaccine development is very long term and very expensive. 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.