To: Art Baeckel who wrote (56 ) 9/30/2002 3:09:09 PM From: keokalani'nui Read Replies (1) | Respond to of 85 ID Biomedical announces FluINsure(TM) vaccine results presented at ICAAC TRADING SYMBOLS - NASDAQ - "IDBE", TSE - "IDB" Monday September 30, 2:00 pm ET VANCOUVER, Sept. 30 /PRNewswire-FirstCall/ - ID Biomedical announced today that Dr. Scott Halperin of the Clinical Trials Research Center at IWK Health Centre and Dalhousie University in Halifax, Nova Scotia, presented Phase I Clinical Trial results for the FluINsure(TM) flu vaccine at the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Diego, CA. The FluINsure flu vaccine is the Company's intranasally administered, non-living vaccine for the prevention of influenza. The clinical trial demonstrated that FluINsure(TM), which is a trivalent product, was strongly immunogenic. Statistically-significant increases in both serum hemagglutination inhibiting (HAI) antibody and in virus-specific secretory IgA antibodies in the nose were shown for all three types of influenza viruses (A/H1N1, A/H3N2, and B) represented in the vaccine. Serum HAI antibody is an accepted correlate of immunity to influenza, and nasal secretory IgA antibody responses have received attention as an additional marker of disease resistance induced by live, attenuated nasal influenza vaccines. In addition, FluINsure was well-tolerated by healthy adults in this randomized, double-blinded, and placebo-controlled trial. Only mild and short- lived runny nose was associated with the active vaccine when compared to placebo. "Based on the results of this trial, the FluINsure flu vaccine appears to be quite competitive, in terms of both safety and immunogenicity, with other nasal flu vaccines," said Dr. Halperin. "These are very encouraging results," said Dr. Louis Fries, Vice President for Clinical and Regulatory Affairs. "Across all subjects who got active vaccine, the average increase in serum HAI antibody levels to all three viruses was 3.2-fold. However, if you consider those subjects who entered the study with levels of serum HAI antibody below the presumed protective level - those who needed protection - the average increase was 5.3-fold. Virus- specific nasal IgA responses, which are technically harder to measure, were also strong in both all subjects and in subjects without clear pre-existing immunity, averaging 2.3 to 2.6-fold. While the two-dose group did have larger antibody rises, we were pleased to see significant immune responses in every treatment group. Overall, we saw significant, potentially protective, serum and/or nasal antibody responses in 71, 87, and 90% of subjects who entered the study without evidence of existing immunity to the A/H1N1, A/H3N2, or B viruses, respectively."