FluINsure vaccine challenge study in U.K. is approved.

2002 NOV 20 - (NewsRx.com & NewsRx.net) -- ID Biomedical announced that it has received a favorable response from the Medicines Control Agency of the United Kingdom with regard to its application to conduct a phase II human "challenge" study for the FluINsure vaccine, company's intranasally delivered trivalent influenza vaccine.

A clinical trial exemption (CTX) has been granted that allows the company to pursue its planned phase II safety, immunogenicity, and challenge studies in London, England. ID Biomedical expects the study to begin in December 2002.

"This CTX is a very significant step in our clinical trial program for the FluINsure vaccine," said Louis Fries, MD, ID Biomedical. "Although we have been very pleased with the serum and mucosal antibody responses generated in our human clinical trials to date, and it is further true that these type of responses have been known to correlate with protection against influenza, seeing what level of protection can be established by the FluINsure vaccine in a human challenge study will be very meaningful and important data."

Results of clinical trials completed thus far have shown that the FluINsure influenza vaccine stimulates a significant immune response in both the blood stream and on the mucosal surfaces of the respiratory tract. ID Biomedical is now pursuing challenge studies, in which immunized subjects in a quarantine facility are intentionally exposed to live influenza viruses to determine if immune responses to the FluINsure vaccine translate into protection against illness.

The company also announced that a preclinical challenge study in the accepted animal model confirmed both the promise and safety of the FluINsure vaccine.

"We are very encouraged by the clinical immunogenicity data from the FluINsure program. In addition to those data, we have also been working to assess the ...