Tuesday September 26, 7:16 am Eastern Time
Press Release
SYNSORB Biotech Inc. Announces Update on
SYNSORB Pk Development Program
CALGARY, Alberta--(BUSINESS WIRE)--Sept. 26, 2000--SYNSORB Biotech
Inc. (``SYNSORB'') (TSE:SYB. - news; NASDAQ:SYBB - news) today
announced an update on the SYNSORB Pk® development strategy
following interactions with regulatory authorities in Canada and the United States.
Following results from the sub-group data in the SYNSORB Pk® Phase III interim analysis announced in July, the
Company has been engaged in discussions with the US Food and Drug Administration (FDA) and Health Canada's
Therapeutic Products Directorate. Through these discussions, it has been concluded that an additional clinical trial
will be required to complete development of SYNSORB Pk®.
The Company has therefore moved into the planning stage for a new Phase III clinical study to validate the earlier
sub-group data and the hypothesis that SYNSORB Pk® is safe and effective in preventing Hemolytic Uremic
Syndrome (HUS) when administered to children within the first 48 hours from the onset of diarrhea symptoms
following E. coli infection.
``It remains our goal to complete the SYNSORB Pk® development program,'' said Dr. David Cox, President and CEO
of SYNSORB. ``However, several factors must first be assessed including anticipated number of patients,
availability of sites, overall budget for the study, potential returns on investment and collaboration of partners.
Only when these have been fully examined will we be able to establish milestones for the program.''
About SYNSORB Pk®
SYNSORB Pk® is a drug designed to prevent serious complications associated with verotoxigenic E. coli (VTEC)
infections (including E. coli O157:H7). A proportion of patients who become infected with E. coli will go on to
develop Hemolytic Uremic Syndrome (HUS), a severe and sometimes fatal kidney disease. Children and the elderly
are most likely at risk of developing HUS, which can lead to a lifetime of dialysis and other serious complications.
SYNSORB Pk® has been granted Fast Track Product designation by the US FDA, which is only given to those
products that are designed to treat serious, life-threatening conditions for which there is no satisfactory treatment.
SYNSORB Biotech Inc.
SYNSORB is a Canadian-based pharmaceutical company dedicated to drug development and manufacturing. In
addition to SYNSORB Pk®, the Company has a second Phase III product, SYNSORB Cd® which has also been
granted ``Fast Track'' designation by the FDA. SYNSORB Cd® is a potential treatment for recurrent C. difficile
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 SYNSORB's carbohybrid program.
Shares of SYNSORB Biotech Inc. trade on the Toronto Stock Exchange in Canada (symbol ``SYB'') and on
NASDAQ in the United States (ticker ``SYBB'').
This release contains certain forward-looking statements which involve known and unknown risks, delays,
uncertainties and other factors not under the Company's control which may cause actual results, performance or
achievements of the Company to be materially different from the results, performance or other expectations implied
by these forward-looking statements. These factors include results of current or pending clinical trials, actions by
the FDA/HPB and those factors detailed in the Company's registration statement on Form 20 F filed with the
Securities and Exchange Commission. |
