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GelVac(TM) Nasal Powder H5N1 (Bird Flu) Influenza Vaccine Passes Preclinical Toxicology Studies
Date:1/15/2008

and well tolerated. The GelVac(TM) nasal powder formulation with the H5N1 vaccine antigen is planned to enter a Phase I study in 2008.

"The successful completion of these preclinical toxicology studies is a major milestone in developing this H5N1 vaccine based on our GelVac(TM) nasal powder technology," stated Carlton E. Turner, PhD, president and CEO of Carrington. "In addition, the completion of the second pre-IND meeting has clearly laid out the development path toward clinical studies. These developments further demonstrate the feasibility of the GelVac(TM) nasal powder platform technology which can greatly expand the availability and coverage of vaccines with its distinct advantages over current liquid needle-based and nasal mist formulation technologies."

Dr. Turner added, "There is a true paradigm shift underway in vaccines from the classical needle delivery to a more user-friendly application. FluMist(R) by MedImmune started the shift, and I believe our nasal powder technology will complete the shift to a patient-friendly vaccination formulation and will open up markets that cannot be served by current vaccines systems."

Dr. Yawei Ni, chief scientific officer of DelSite, added, "Our nasal powder vaccine platform has been shown to work with many antigens, is stable at room temperature, requires no needles, no preservatives, and no cold storage, and can be shipped free of the restrictive cold chain distribution systems associated with vaccines. Moreover, our system is particularly well suited for influenza pandemic preparedness, bio-defense applications, and vaccine coverage in areas lacking basic infrastructures."

GelVac(TM) powder platform possesses other distinct, practical features. The GelSite(R) polymer used in the formulation is derived from a natural source and is stable over four years at room temperature. The polymer binds to and stabilized proteins and peptides. An influenza vaccine incorporating a, non-egg based, H1N1 an
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SOURCE Carrington Laboratories, Inc.
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