BioSante Announces CAP Nanotechnology Product Development and Business Update.Business Editors/Health/Medical Writers BIOWIRE2K LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Feb. 2, 2004 BioSante Pharmaceuticals, Inc. (Amex:BPA BPA British Paediatric Association. ) today announced an update on recent developments of its calcium phosphate-based nanotechnology (CAP). "To date we have made significant progress in development of our proprietary CAP nanotechnology," said Stephen M. Simes, BioSante's president and chief executive officer. "Currently, CAP nanotechnology is being developed for two lead uses, namely safer and more effective vaccines and therapeutic drug delivery, primarily proteins. We are product-focused and determined to continue to make progress in all areas." To date, the following has been accomplished regarding development of CAP nanotechnology:
-- Product clinical and pre-clinical developments:
-- Phase I human clinical study completed, showing safety
of injected CAP.
-- Positive results in several animal models using CAP as
a safer vaccine adjuvant to improve the efficacy of
vaccines versus no adjuvant and versus alum, the only
FDA-approved vaccine adjuvant.
-- Positive results in animal models for the
sustained-release delivery of therapeutic proteins,
including long-acting injectable insulin, inhaled
insulin and oral insulin, among other proteins tested.
-- Current business and product development agreements:
-- Corixa Corporation: (non-exclusive) for use of CAP in
cancer, and infectious and autoimmune disease
vaccines.
-- U.S. Navy: (CRADA) for evaluation and development of a
malaria vaccine.
-- U.S. Army: (CRADA) for evaluation and development of
needle-free biodefense vaccines including anthrax,
staph, ricin and bubonic plague.
-- DynPort: U.S. DOD subcontract ($658,000) for
evaluation and development of a needle-free anthrax
vaccine.
-- NIH: SBIR grant ($100,000) for oral insulin
development.
BioSante scientists will be presenting at upcoming scientific meetings, including a vaccine presentation at the World Vaccine Conference 2004 in Montreal in April and on insulin at the Controlled Release Society Meeting in Honolulu in June. BioVant(TM) is being developed as a vaccine adjuvant adjuvant /ad·ju·vant/ (aj?dbobr-vant) (a-joo´vant) 1. assisting or aiding. 2. a substance that aids another, such as an auxiliary remedy. 3. and delivery system for new, improved and less toxic vaccines by various routes of administration including traditional injection and alternative routes of administration, such as nasal nasal /na·sal/ (na´zil) pertaining to the nose. na·sal adj. Of, in, or relating to the nose. nasal pertaining to the nose. , oral and needle-free transcutaneous transcutaneous /trans·cu·ta·ne·ous/ (-ku-ta´ne-us) transdermal. trans·cu·ta·ne·ous adj. Transdermal. routes. In the CRADAs, which are Cooperative Research and Development Agreements “CRADA” redirects here. For other uses, see CRADA (disambiguation). A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together. , the U.S. Navy and Army have provided various vaccine antigens Antigens Markers on the outside of such organisms as bacteria and viruses, which allow antibodies to recognize foreign invaders. Mentioned in: Measles, Q Fever, Severe Combined Immunodeficiency to be formulated with BioVant. BioSante scientists are formulating and sending the potential vaccine to the Navy or Army for pre-clinical testing. The pre-clinical testing is funded by the respective military service. In the case of the DynPort subcontract sub·con·tract n. A contract that assigns some of the obligations of a prior contract to another party. intr. & tr.v. sub·con·tract·ed, sub·con·tract·ing, sub·con·tracts , BioSante is being provided with the vaccine antigen and will conduct the pre-clinical studies, funded by the Department of Defense. BioOral(TM) is being developed for the oral delivery of proteins such as insulin, growth hormone growth hormone or somatotropin (sōmăt'ətrō`pən), glycoprotein hormone released by the anterior pituitary gland that is necessary for normal skeletal growth in humans (see protein). and other therapeutic proteins that currently must be injected in·ject·ed adj. 1. Of or relating to a substance introduced into the body. 2. Of or relating to a blood vessel that is visibly distended with blood. injected 1. introduced by injection. 2. congested. . The $100,000 National Institutes of Health grant will help fund development of an oral formulation of insulin by BioSante scientists. The current vaccine market is approximately $9 billion and is predicted to triple in value by 2012. Interest in vaccine production is spurred by increased demand for flu vaccination vaccination, means of producing immunity against pathogens, such as viruses and bacteria, by the introduction of live, killed, or altered antigens that stimulate the body to produce antibodies against more dangerous forms. , vaccines for use by tourists visiting tropical countries and fears of bioterrorism bi·o·ter·ror·ism n. The use of biological agents, such as pathogenic organisms or agricultural pests, for terrorist purposes. Bioterrorism . The market for insulin is over $4 billion and increased 15.1 percent from 2001 to 2002. Diabetes affects 17 million Americans and is the country's fifth-leading cause of death. About BioSante Pharmaceuticals, Inc. BioSante is developing a pipeline of hormone therapy Hormone therapy Treating cancers by changing the hormone balance of the body, instead of by using cell-killing drugs. Mentioned in: Breast Cancer, Thyroid Cancer hormone therapy products to treat both men and women. The company is also developing its nanotechnology (CAP) for novel vaccines, vaccine adjuvants and drug delivery systems. Additional information is available online at www.biosantepharma.com. This news release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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," 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, adverse reports from others about products similar to ours, 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 17 to 23 of BioSante's Form 10-KSB, which discussion also is incorporated herein by reference. |
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