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Biotech / Medical : idb/to..idbe/nas long term growth -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (78)	1/13/2005 1:14:19 PM
From: tuck	Read Replies (1) \| Respond to of 85

>>VANCOUVER, Jan. 13 /PRNewswire-FirstCall/ - ID Biomedical Corporation (TSX: IDB - News; NASDAQ: IDBE - News) announced today that it has completed analysis of the vaccine immunogenicity and safety data from its 2003/04 field efficacy trial of FluINsure(TM), a non-living intranasally delivered influenza vaccine. The trial was carried out in 1,349 healthy subjects aged 18 to 64 in 28 Canadian sites between October 2003 and May 2004. As previously reported, both one- and two-dose FluINsure regimens were efficacious in preventing influenza-like illness (two or more symptoms) in association with a positive influenza virus culture and no FluINsure recipient experienced febrile illness associated with culture-confirmed influenza. The immunogenicity data from the study showed a significant rise in serum hemagglutination-inhibiting (HAI) antibody titers, a widely accepted correlate of protection against influenza disease, when vaccinees were compared to placebo recipients. The increases in HAI titers were highly significant (p less than or equal to 0.001 vs. placebo recipients) for all three vaccine viruses (A/H1N1, A/H3N2, and B). The increases in HAI titers were statistically indistinguishable between vaccinees who received two doses and those who received a single dose of FluINsure(TM). In addition, significant rises (p less than 0.001) in salivary secretory IgA specific for the vaccine viruses were also found for all three vaccine viruses among subjects who received the active vaccine, but not those who received placebo. Salivary secretory IgA responses were not significantly different between subjects who received the two dose regimen and those who received one dose. With regard to safety, there was no statistically significant association of local or respiratory complaints (runny nose, stuffy nose, itchy nose, nose bleed, sneezing, sore throat, red or puffy eyes, wheezing or cough) with active vaccine when compared with placebo (saline). Similarly, neither temperature elevations nor systemic complaints (headache, muscle or joint aches, tiredness, or loss of appetite) were related to receipt of FluINsure at either dosage level. Throughout the study period, there was no statistically significant difference in the overall incidence of adverse events reported between the vaccine and placebo groups, and there was no significantly increased rate of any particular class of adverse events in vaccine recipients versus placebo recipients. "These are very encouraging results. In a large field study, we were able to clearly demonstrate both the systemic and mucosal immune responses to the viruses represented in the vaccine," commented Louis F. Fries, M.D., Vice President, Clinical and Medical Affairs. "The immunogenicity trends that we showed in smaller studies have been validated, and we have shown immune responses to the single-dose regimen that are in agreement with its efficacy. The serum HAI antibody responses to the influenza A viruses induced by FluINsure were quite robust in the context of a mucosal vaccine, and while HAI responses to the B component were lower (a frequent finding with B virus antigens in all influenza vaccines), they remained significant. Furthermore, we have been able to demonstrate mucosal antibody responses using saliva, which is a relatively easy specimen to obtain and suitable for large field studies, that parallel our data in the more difficult nasal wash system. This will be a useful tool in future studies. Finally, the strikingly benign safety profile of FluINsure continues to be confirmed." ID Biomedical also announced that it has completed enrollment of a reimmunization study in Canada, testing FluINsure formulated with the flu antigen acquired through the Company's purchase of Shire Pharmaceuticals' vaccine assets. All subjects have been enrolled and have received a single dose of FluINsure. The objective of this study is to demonstrate that the vaccine is well tolerated and gives a strong immune response in those persons who have received the vaccine in the previous flu season. The Company expects to have results of this study in spring 2005. ID Biomedical plans to initiate its first pediatric clinical studies of FluINsure in the U.S. toward the end of 2005.<< snip Cheers, Tuck