Clinical Overview of Development Activities
Currently, the company’s devices are being used many clinical research projects both within and outside of the United States. These research projects are being conducted by companies engaged in the development of vaccines, therapeutics, DNA-based medications and other injectables, as well as by universities and governmental institutions conducting research in these areas.
MPI Research Collaboration
Bioject has established a strategic alliance with MPI Research, a leading pre-clinical research organization with experience in the development of injectable therapeutics. The strategic alliance creates a preferred partnership relationship which allows Bioject to gain access to a range of capabilities and resources needed for the company to explore our drug+device opportunities, including access to pharmacologic, analytical, safety and other preclinical testing resources available at MPI Research. The strategic alliance offers MPI Research the opportunity to provide Bioject’s needle-free technology as an alternate delivery option to current drug/biologic manufacturers who may be interested in seeking a more highly competitive and differentiable drug+device brand.
“Bioject and MPI Research share an innovative and entrepreneurial spirit that creates a synergy vital to our industry. It is a pleasure to collaborate with a company that has such highly-developed technological expertise and strategic vision.”
Bill Parfet, CEO and Chairman of MPI Research
MPI Research, with global headquarters in Mattawan, Michigan, is one of the world’s leading providers of comprehensive preclinical and early clinical research and development services. In addition to a wide array of drug safety evaluation services, MPI Research also has a Discovery Center that offers experimental therapeutics (in vivo, molecular and cell-based assays), experimental surgery, molecular imaging, drug metabolism, pharmacokinetics, and immunology. The company also offers medical device evaluation, bioanalytical and analytical testing and other medical development services. Learn more about the company’s commitment to be the best at www.mpiresearch.com.
DNA Based Vaccines
One of Bioject’s current research initiatives is in clinical research of DNA-based vaccines and medications. Developing DNA-based preventative and therapeutic treatments for a variety of diseases is a very active and growing area of medical research. Researchers hope to develop DNA-based treatments for diseases that have previously not been treatable as well as DNA-based alternatives to therapies currently used in the treatment of other diseases. Most DNA therapies currently being developed require injecting the medication either intramuscularly or intradermally.
Bioject has developed an adapter* that allows the Biojector® device to consistently deliver intradermal injections. This adapter is being used in clinical studies to deliver intradermal injections. Initial studies show the adapter to be effective. Pre-clinical testing in animals provided consistent data indicating effective intradermal injections. This adapter has not yet been cleared by the FDA to be marketed for intradermal injections and is not currently submitted to the FDA to gain clearance for those claims.
If the Company’s jet injection technology is proven to enhance the performance of DNA-based medications, this area of medicine could present a significant opportunity for Bioject to license its products to pharmaceutical and biotechnology companies for use in conjunction with their DNA-based medications.
*Investigational use only