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

To: gg cox who wrote (2)	2/4/2000 11:57:00 AM
From: gg cox	Read Replies (1) \| Respond to of 85

N post article (today) from stockhouse.. ID Biomedical expects FDA to approve trials Strep vaccine: Regulator had imposed 25-year ban Drew Hasselback Financial Post VANCOUVER - ID Biomedical Corp. said yesterday it expects the U.S. Food and Drug Administration to approve further testing for its vaccine against Group A streptococcus, a bacteria responsible for everything from sore throats to flesh-eating disease. An FDA official contacted yesterday refused comment, saying a U.S. law bars the regulator from speaking about the status of approvals. But Dean Linden, an ID spokesman, insisted FDA approval is imminent for the company to continue its human tests at higher dosages of the vaccine. ID's experimental vaccine is interesting in the light of the FDA's 1979 decision to ban licensing for Group A strep vaccines for 25 years. The ban flowed from concerns that an earlier experiment for a possible Group A strep vaccine triggered rheumatic fever. While the FDA's licensing ban did not prohibit clinical trials for possible Group A strep vaccines, pharmaceutical companies lost interest in developing them because the ban meant that even a successful vaccine would never have been allowed on the market. That changed last October when ID became the first company in 20 years to launch a clinical trial for its proposed vaccine. The initial Phase I study, which is taking place at the University of Maryland, involves administering a test vaccine to 30 human volunteers. ID now has the initial results from that study. According to Dr. Anthony Holler, a former emergency room medical doctor who is now president of ID, the results suggest that not only is the vaccine safe, but also that it is generating antibodies that could immunize people from a variety Group A strep bug strains. "We know we've hit a home run," Dr. Holler said. Development of ID's experiemental vaccine is still at a very early stage. It could be another five years before ID finishes testing the vaccine in humans, then obtains FDA approval for commercialization. The licensing ban remains on the books, but FDA has said that it is considering dropping it. Group A strep has been linked to a variety of illnesses. Some, such as strep throat, can be treated with antibiotics. But others are far more dangerous. Jim Henson, creator of the Muppets, died in 1990 from a pneumonia caused by the bug. And Lucien Bouchard, Quebec's Premier, lost a leg to "flesh-eating disease", a rare strain of Group A strep.