>>VANCOUVER, July 8 /PRNewswire-FirstCall/ - ID Biomedical Corporation announced today that analysis of nasal antibody levels from the Company's Phase I Clinical Trial of FluINsure(TM), a novel subunit influenza vaccine for nasal administration, showed that all dose levels of the vaccine tested gave statistically- significant increases in nasal antibodies against the influenza viruses represented in the vaccine. These findings complement the encouraging serum antibody response data that were reported previously from this study.
The Phase I trial was conducted at the Clinical Trials Research Center (CTRC) at Dalhousie University and the IWK Health Centre in Halifax, Nova Scotia by Dr. Scott Halperin, Professor of Pediatrics and the CTRC's Director. The double-blinded placebo-controlled study focused on the safety and immunogenicity of four escalating doses of FluINsure in 78 healthy adult volunteers.
Louis Fries, M.D., Vice President for Clinical and Regulatory Affairs for ID Biomedical, said, "With this new data, we have expanded our understanding of the immune responses evoked by FluINsure. We were able to demonstrate statistically significant increases in the levels of secretory IgA (sIgA) antibodies in nasal washings that are directed against all three viruses in the trivalent vaccine. These results are very encouraging, especially when coupled to the strong serum antibody responses we reported earlier. There is an increasing appreciation of the role of virus-specific sIgA antibody in the nose and respiratory tract as an important mediator of influenza immunity. We were also pleased to find that, when compared to published data regarding the cold-adapted live virus nasal vaccine in healthy adults, FluINsure induced nasal sIgA responses in at least as great a proportion of subjects, and that the magnitude of these responses was as great as, or greater than, those reported in subjects who received the live vaccine."
Data from the clinical trial will be presented in greater detail by Dr. Halperin at the 42nd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Diego, CA, on 29 September, 2002 (www.icaac.org/42ICAAC/Accepts.asp).
FluINsure has recently entered Phase II Trials designed to determine an optimal formulation and dose, and expand its safety and immunogenicity database.
FluINsure is based on the Company's proprietary Proteosome(TM) vaccine delivery/adjuvant technology. The flu vaccine is created by combining Proteosome proteins with a purified preparation of influenza proteins that includes the hemagglutinin protein. Importantly, unlike some other nasal influenza vaccines in development, FluINsure contains no live viruses. Intranasal vaccines based on the Proteosome delivery system, and incorporating a variety of antigens in addition to influenza, have now been tested in over 320 people and have had a good safety profile.<<
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Cheers, Tuck |
