Canadian Company Press Release
SYB 2000-01-11 (provided courtesy of Canadian Corporate News.)
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SYNSORB Biotech Inc. Announces SYNSORB Cd(R) Receives Fast Track
Product Designation From US Food And Drug Administration
CALGARY, ALBERTA--SYNSORB Biotech Inc. ("SYNSORB") (TSE: SYB;
Nasdaq: SYBB) today announced that SYNSORB Cd(R) has received
formal notification of Fast Track Product designation ("Fast
Track") from the United States Food and Drug Administration (FDA)
for the prevention of recurrence of Clostridium difficile
associated disease (CDAD), a common condition often associated
with antibiotic use, AIDS and chemotherapy.
"This is a very significant development for SYNSORB Cd(R),"
explained Dr. David Cox, President and CEO of SYNSORB. "Once and
for all it settles the debate about whether or not CDAD is a
severe illness. The FDA has confirmed that not only is recurrent
CDAD a serious, life-threatening disease, but there is also no
satisfactory treatment for it. If shown to be successful in our
Phase III trials, due to commence shortly, SYNSORB Cd(R) could
eventually offer enormous clinical benefit to those hundreds of
thousands of patients suffering from the disease, and for whom
there are no other options."
Fast Track is a highly desirable designation for drugs undergoing
clinical development, and is only granted to products that are
intended to treat serious or life-threatening conditions, and for
which there is an unmet medical need. Fast Track drugs receive
special assistance and support from the FDA during their
development and the review process for these products is shorter
than would otherwise be the case, thus allowing the drugs to reach
market more quickly, if approved. Fast Track designation has been
granted to SYNSORB Cd(R) because the FDA considers CDAD a serious
or life-threatening disease, and they believe that SYNSORB Cd(R)
offers a new therapy that can potentially treat this serious
illness.
CDAD is a disease which is a common complication of antibiotic
use. It is highly infectious, and therefore is quite prevalent in
health care institutions such as hospitals and nursing homes. The
disease can be very debilitating, and patients suffering from
recurrent CDAD can expect to remain hospitalized up to 26 days
longer, and the fatality rate for untreated patients has been
estimated to be between 27% and 44%. There is no satisfactory
treatment available for patients suffering from recurrent CDAD.
SYNSORB is a Canadian-based pharmaceutical company dedicated to
drug development and manufacturing. The Company has two
late-stage products, both of which are based on SYNSORB's
proprietary carbohydrate chemistry platform technology. SYNSORB
Pk(R) is in Phase III clinical trials, and is designed to prevent
the progression to Hemolytic Uremic Syndrome (HUS) in children who
have contracted verotoxigenic E. coli (VTEC) infections, including
E. coli O157:H7. SYNSORB Cd(R) will commence Phase III trials in
the first part of 2000, and is designed to treat recurrent
antibiotic-associated diarrhea (CDAD), a common hospital acquired
infection. SYNSORB has built a cGMP-compliant manufacturing
facility that has the capacity to meet or exceed the expected
global demand for the Company's products. A pipeline of future
products is accessible through subsidiary companies and SYNSORB's
carbohybrid program. |
