BioSante Pharmaceuticals, Inc. 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 diseasevaccines.
- 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 is being developed as a vaccine adjuvant 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, oral and needle-free transcutaneous routes.
In the CRADAs, which are Cooperative Research and Development Agreements, the U.S. Navy and Army have provided various vaccine antigens 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, BioSante is being provided with the vaccine antigen and will conduct the pre-clinical studies, funded by the Department of Defense.
BioOral is being developed for the oral delivery of proteins such as insulin, growth hormone and other therapeutic proteins that currently must be injected. 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, vaccines for use by tourists visiting tropical countries and fears of 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.