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/.
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.