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Biotech / Medical : Oncothyreon -- Ignore unavailable to you. Want to Upgrade?

To: Tom Cat who wrote (686)	5/11/1999 8:42:00 PM
From: Jibacoa	Read Replies (1) \| Respond to of 2344

The "bridging study" is because the Theratope Vaccine that Biomira is presently using on the on going Phase III is not exactly the same as it used on the Phase II. The new vaccine has been shown in vitro, to be 100 times more immunogenic against the MUC1 antigen. Biomira got the OK from the FDA to proceed to the Phase III using the new version of the vaccine, without having to repeat the Phase II, but conducted a "bridging study" in 18 patients to show that there were no deleterious or increased "side effects". The results of that "bridging study" supposedly were available when Biomira embarked on the Phase III, but are going to be officially reported at the ASCO conference. Showing that the vaccine has no more side effects in spite of being 100 times more immunogenic against the tumor, bodes well for the eventual results of the Phase III. Remember also that Biomira has said they expect to take "an early look" at result from the Phase III about 24 months "from the start". Since the Phase III started 6 months ago, that means we may have "early results" by the third quarter next year, and if they come out as expected, BIOM plans to apply for an "EXPEDITE APPROVAL", which means that it could be starting to sell Theratope Vaccine for breast cancer while the Phase III is still in progress. Bernard