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. |
