CytoDyn Selects Waisman Facility to Manufacture Its DNA-Based Pre-Flu Vaccine
Posted on: Wednesday, 14 March 2007, 09:01 CDT
CytoDyn, Inc. (Pink Sheets:CYDY) has selected the Waisman Clinical BioManufacturing Facility at the University of Wisconsin at Madison to manufacture the Company's DNA-based pre-flu vaccine. CytoDyn's pre-flu vaccine provides an alternative approach to immunization that could make flu vaccines for the seasonal flu and bird flu more effective. It uses DNA technology to implant a false memory of previous exposure to the flu virus, including the inactivated virus contained in standard vaccines.
Dr. Peggy Pence, who has oversight over the Company's clinical development, cautions that careful consideration must be given to the design and conduct of toxicology studies, initial clinical trial design, and overall development plan, all with the advice of the FDA, in order to have an appropriate IND, a prerequisite to successful human studies. Assuming all goes well, the Company hopes to have clinical trials underway before the end of next year's flu season, according to the Company's CEO Allen D. Allen.
Located at the University of Wisconsin-Madison's Waisman Center, the Waisman Clinical BioManufacturing Facility (WCBF) is designed to manufacture clinical-grade biological pharmaceuticals for Phase I and II human clinical trials. In addition to facilities and equipment for producing plasmid DNA, WCBF has facilities for processing cell therapeutics, aseptic filling of parenteral therapeutics, and for producing recombinant proteins expressed in bacterial or mammalian systems. WCBF is also capable of providing services such as process development, analytical methods development, analysis of biologics, and quality assurance. With its broad and comprehensive capabilities, WCBF can provide assistance to investigators and companies throughout the entire process of developing a manufacturing process, including production and testing materials for human clinical trials.
This press release contains forward-looking statements that are not historical facts. The Company's management makes forward- looking statements concerning the Company's expected future operations, performance and other developments. These forward-looking statements are necessarily estimates based upon current information and involve a number of risks and uncertainties. There can be no assurance that such risks and uncertainties, or other factors, will not affect the accuracy of such forward-looking statements. It is impossible to identify all factors that could cause actual results to differ materially from those estimated by the Company. They include, but are not limited to, government regulation, managing and maintaining growth, victimization by white-collar offenders, and the effects of adverse publicity, litigation, competition, and other factors that may be identified from time to time in the Company's announcements.
Source: Business Wire
Related Articles
- Cangen Biotechnologies Inc. And Dai Nippon Printing Co., Ltd. Move Forward With Development Of An Early Stage Lung Cancer Diagnostic
- Inovio Biomedical Provides Updated Interim Data on Phase I/II Clinical Study of Electroporation-Delivered Prostate Cancer DNA Vaccine at ASGT Annual Meeting
- Accentia Biopharmaceuticals Updates Interim Analysis of Blinded Clinical Results in the Fast-Tracked Pivotal Phase 3 Trial of SinuNase for the Treatment of Refractory Chronic Sinusitis
- Lipoxen Announces $75M Agreement With Baxter to Develop New Blood Clotting Factors
- Inovio Biomedical and Tripep Advance Pre-Clinical Development of DNA Vaccine for Hepatitis C
- Bernanke Says Fed Policy Must Be Forward-looking
- EPIX Pharmaceuticals Pre-Clinical Research Program Optioned for Development
- Westinghouse Lauds Progress Energy for Proactive, Forward-Looking Approach to Nuclear Fleet Expansion
- Sinovac Receives Government Funding for Pandemic Flu Vaccine Research and Development
- GlycoGenesys, Inc. Provides Update on Corporate and Clinical Plans Going Forward
 |
 |
User Comments (0)
RSS Feeds