ID Biomedical has received permission from Health Canada to proceed with the Phase I Clinical Trial of FluINsure, a vaccine for the prevention of influenza that is administered by nasal spray. Additionally, the Company announced that it has been informed by the Clinical Trials Research Center (CTRC) that the first group of adult volunteers has been vaccinated.
The trial, which is being conducted by Dr. Scott Halperin, Professor of Pediatrics at Dalhousie University, and Director of the CTRC, is focused on the safety and immunogenicity of FluINsure in approximately 80 healthy adult volunteers. Initial results from this study are expected by the end of the first quarter of 2002.
Dr. Louis Fries, Vice President for Clinical and Regulatory Affairs for ID Biomedical said, "In this trial, we are going to follow up on the encouraging data we've developed with our monovalent prototype vaccine, now using a commercializable trivalent formulation. We will be looking at several dose levels, but most importantly confirming the evidence from the monovalent studies that our intranasal flu vaccine will be well-tolerated and strongly immunogenic."
Results from the two previous human studies testing a monovalent formulation for FluINsure using one or two dose regimens and a variety of dose levels have shown the vaccine to be well tolerated. Additionally, subjects developed influenza-specific antibodies in the blood stream (serum hemagglutination-inhibiting antibodies) and in nasal secretions (secretory IgA antibodies). Serum hemagglutination-inhibiting antibodies are considered to be a key predictor of resistance to influenza and there is evidence from experimental studies that nasal secretory IgA responses also correlate with protection against the virus.
ID Biomedical's flu vaccine is based on the Company's proprietary vaccine delivery/adjuvant technology, Proteosomes. The flu vaccine is created by combining Proteosomes with a purified preparation of influenza proteins that includes the hemagglutinin protein.