Carrington subsidiary DelSite receives H5N1 (Bird Flu) antigen to develop nasal powder flu vaccine

Toxicology Studies to Start in August 2007

18-Jul-2007

DelSite Biotechnologies, wholly-owned subsidiary of a Carrington Laboratories, Inc., took delivery of several thousand doses of the H5N1 influenza (bird flu) antigen from a secured source. DelSite is preparing to initiate America's first clinical program of a nasal powder bird flu vaccine, combining the H5N1 antigen with a new dry powder delivery platform.

An IND filing for Phase I human safety study is planned later this year pending successful results of toxicology studies which are scheduled to begin within 30 days.

Successful development of a nasal dry powder bird flu vaccine may fill key needs in national preparedness against an influenza pandemic, accelerating the swiftness by which people could be inoculated against a potentially deadly threat. The Carrington-DelSite technology allows for stockpiling of vaccine supplies and shipment without refrigeration. The dry powder-based vaccine may also be self-administered without the use of needles or the need for attending healthcare professionals.

The dry powder delivery platform GelVac(TM) contains the unique GelSite(R) polymer, also developed and manufactured by DelSite. The GelSite(R) polymer enables in situ gelling of the vaccine powder when introduced into the nasal passages, the polymer adheres to the mucosal lining and provides prolonged residence time that, in turn, increases antigen delivery. Other unique features of the delivery platform include room temperature stability, prolonged shelf life, and needle-free administration. Because refrigerated transportation and storage are not required, GelSite(R) technology could greatly enhance vaccination programs in developing countries where conventional therapies and preventives are not practical, thus contributing to greater worldwide pandemic preparedness.

A Phase I safety study of the GelVac(TM) powder delivery system without antigen was successfully completed, and it serves as the basis for the upcoming clinical testing of the system with the bird flu antigen.

Dr. Yawei Ni, DelSite's chief scientific officer, stated, "During the past year we've honed our manufacturing process for the GelVac(TM) formulation and are now able to produce greater quantities in less time, with consistent results. We anticipate the toxicity studies with the antigen will produce the desired results, and are eager to move forward to the human clinical testing phase."

https://www.bionity.com/en/news/66289/carrington-subsidiary-delsite-receives-h5n1-bird-flu-antigen-to-develop-nasal-powder-flu-vaccine.html