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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 (57)	12/3/2002 10:39:32 AM
From: tuck	Read Replies (2) \| Respond to of 85

>>VANCOUVER, Dec. 3 /PRNewswire-FirstCall/ - ID Biomedical today announced positive results on its two Phase II Clinical Trials of FluINsure(TM), the Company's intranasally delivered influenza vaccine. Results of these ongoing, randomized, double blind and concurrent placebo-controlled studies, which enrolled a total of 99 healthy adult subjects, confirm the positive results of the previously reported Phase I study. The FluINsure vaccine continued to exhibit a favorable safety and tolerability profile, with no serious adverse events and only mild and transient nasal stuffiness and/or runny nose being associated with the active vaccine when compared to a placebo nasal spray. Statistically-significant increases in serum hemagglutination-inhibiting (HAI) antibodies were induced by all regimens tested, including both one- and two-dose regimens, at 28 days post immunization. For both influenza A strains included in the vaccine, serum HAI antibody titers increased by an average of 2.4-fold in the one-dose group and 2.5-fold in the two-dose groups. Among those subjects who had low pre-existing serum HAI titers prior to immunization with the FluINsure vaccine (suggesting that they were therefore more susceptible to influenza), HAI titers increased an average of 3-fold in one- dose recipients and 4.2-fold in the two-dose groups. Rises in HAI antibodies to influenza B component were lower in all groups likely because of high levels of pre-existing immunity to the influenza B strain in the study population. Statistically-significant rises in nasal secretory antibody levels of 1.7 to 3.2-fold were noted in the two-dose groups. Nasal antibody measurements in the one-dose group are not yet complete. Data from the one-dose group, as well as final data analysis on this Phase II study will be completed in mid January. "We're very pleased with this data," said Dr. Louis Fries, Vice President of Clinical and Regulatory Affairs. "These studies build on the positive data from previous trials and give us important information on the FluINsure vaccine's performance in terms of the consistency from lot to lot. That's a very important point, because we must be able to deal with new strains of the influenza virus each year without changing our production process." Dr Fries also noted, "Overall the serum and nasal antibody results from our studies are clearly competitive with or superior to, those reported in published studies of other nasal flu vaccines that have proven protective in challenge studies and in the field." Dr Fries will be presenting initial data from these studies and summary data from previous studies of the FluINsure vaccine, at the 5th International Symposium on Respiratory Viral Infections, on December 7, 2002. Additionally, the Company reported today that all study subjects in the Phase II Challenge Trial in Great Britain, have received either the FluINsure vaccine or a placebo intranasally (see news release titled 'ID Biomedical announces start of FluINsure(TM) vaccine challenge trial' dated November 26, 2002). Study subjects will be challenged with live influenza in early January and the Company expects to report results in February. These Phase II clinical studies are being conducted to gather data on the FluINsure vaccine in preparation for the first large field trial of protective efficacy, which the Company expects to initiate in time for the 2003-4 influenza season.<< snip Cheers, Tuck