July 16, 2007 — IRVING, TX — Carrington Laboratories, Inc. announced on July 13 that its wholly owned subsidiary DelSite Biotechnologies, Inc. took delivery of several thousand doses of the H5N1 influenza (bird flu) antigen from a secured source and is preparing to initiate America’s first clinical program of a nasal powder bird flu vaccine, combining the H5N1 antigen with DelSite’s novel GelVac(TM) 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 GelVac(TM) powder 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. We’ve worked very diligently over the last several years to bring this technology to fruition, and it is most gratifying and exciting to test its capability in a human clinical setting. I commend DelSite’s dedicated scientific staff for all they have done to bring our technology closer to a proven means which may benefit people around the world.”
Carrington’s wholly owned subsidiary DelSite Biotechnologies, Inc., is developing its proprietary GelSite(R) technology designed to provide controlled release of peptide and protein-based drugs and vaccines. DelSite is currently developing a nasal powder vaccine using its GelVac(TM) formula with the H5N1 avian flu antigen. This work is partially funded by two grants from NIAID (National Institute of Allergy and Infectious Diseases) of NIH (National Institute of Health) under the Department of Health and Human Services.
Carrington Laboratories, Inc. is an ISO 9001-certified, research-based, biopharmaceutical and consumer products company currently utilizing naturally occurring complex carbohydrates to manufacture and market products for mucositis, radiation dermatitis, wound and oral care, as well as to manufacture and market the nutraceutical raw material Manapol(R) and cosmetic raw material Hydrapol(TM). Carrington also manufactures and markets consumer products and manufactures quality products for other companies. Manufacturing operations comply with cGMP standards. Carrington’s technology is protected by more than 130 patents in 26 countries. Select products carry the CE mark, recognized by more than 20 countries around the world. For more information, visit http://www.carringtonlabs.com.