- Human Trials to Begin Later This Year
- Only Nasal Powder Bird Flu Vaccine Under Development
- Patient-Friendly (No Needles); No Preservatives
- Stable at Room Temperature For 3 Years; No Cold Chain Distribution
IRVING, Texas, Feb. 14 /PRNewswire-FirstCall/ -- Carrington Laboratories, Inc. (OTC Bulletin Board: CARN) today announced that its wholly-owned subsidiary DelSite Biotechnologies, Inc. received a shipment of clinical-grade H5N1 (bird flu) antigen from a major pharmaceutical company to commence production, under cGMP requirements, of clinical quantities of DelSite's nasal powder bird flu (H5N1) vaccine. The nasal powder bird flu vaccine is scheduled to begin testing in a Phase I human clinical trial later this year.
The vaccine will utilize DelSite's proprietary GelVac(TM) nasal powder delivery platform, which offers many distinct advantages over traditional vaccine delivery systems: (1) easy, needle-free, self-administration, not requiring healthcare professionals; (2) enhanced protection because administration of vaccine into nasal cavity stimulates both a systemic response and mucosal response; (3) no adverse side effects caused by preservatives; (4) stability at room temperature, which eliminates the need for cold storage or cold chain distribution, thereby opening distribution to Third World countries where refrigeration is often not available; and, (5) a demonstrated shelf life of an influenza vaccine of three years, enabling potential stockpiling in the event of a pandemic.
As a prelude to the Phase I human trials, in January 2008 toxicology
studies were successfully completed on a GelVac nasal powder (H5N1)
influenza vaccine. The GelVac nasal powder platform has also successfully
completed a Phase I safety study in which the delivery device provided a
consistent, greater-than-90-percent delivery of the powder to the desired
|SOURCE Carrington Laboratories, Inc.|
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