November 1/99
SYNSORB Biotech Inc. Announces Company Receives Final Interim Analysis
Report for SYNSORB Cd(R) Phase II Clinical Trial
CALGARY, ALBERTA--
Company also reports on progress of SYNSORB Cd(R) clinical
development plan
SYNSORB Biotech Inc. ("SYNSORB") (TSE: SYB, Nasdaq: SYBB) after
receiving the final report on the interim analysis of the SYNSORB
Cd(R) Phase II clinical trial, reports on the Company's recent
progress in the development of SYNSORB Cd(R) for the treatment of
recurrent Clostridium difficile Associated Diarrhea (CDAD).
The primary objective and expectation of the Phase II trial was to
determine whether SYNSORB Cd(R) could reduce the recurrence rate
in CDAD patients by 50%. In fact, the final report on the interim
analysis of the first 103 patients has confirmed that the group
receiving a 16g/day dose of SYNSORB Cd(R) experienced a very
significant 80% reduction in the rate of recurrence compared to
the group who received the placebo.
SYNSORB began to plan and implement its clinical development
strategy immediately upon releasing the preliminary interim
analysis data on September 13, 1999. Recruitment into the Phase
II trial was halted the same day, much sooner than expected owing
to the exceptional results, and planning for pivotal Phase III
trials to support a New Drug Application (NDA) began immediately.
Execution of the development plan for SYNSORB Cd(R) is well
underway. The required meetings with regulatory authorities in
Canada and the US have been scheduled, sites have been recruited,
bids from potential Clinical Research Organizations (CRO's) to
assist with monitoring the trials are being reviewed and details
of the SYNSORB Cd(R) Phase III clinical trial protocol are in the
final stages of review. Before the end of 1999, SYNSORB intends to
file this protocol and seek approval to begin the Phase III tests.
Once approval is granted, it is expected that patient enrollment
will commence in the first half of 2000. In the meantime,
approval by Internal Review Boards at the sites will be sought.
Manufacturing of clinical trial batches of SYNSORB Cd(R) has
already begun at SYNSORB's new cGMP manufacturing facility in
Calgary.
The compelling nature of the Phase II data has allowed SYNSORB to
commence negotiations with candidates for marketing and
distribution partnerships (for jurisdictions outside of Canada).
The potential size of the market is such that it has captured the
attention of large pharmaceutical companies.
"SYNSORB is committed to expedited clinical development of SYNSORB
Cd(R) and pleased to communicate our progress to shareholders,"
said Dr. David Cox, President & CEO of SYNSORB. "Careful planning
for SYNSORB Cd(R) development is enabling us to proceed as
efficiently and quickly as possible through the required steps in
order to begin pivotal Phase III trials. We intend to continue
this approach through the development program. Concurrently, we
also continue to actively recruit patients into our SYNSORB Pk(R)
Phase III trial for the prevention of HUS."
Primary CDAD is a common disease, which can affect people
undergoing antibiotic therapy, hospitalized patients, or otherwise
immunocompromised individuals. An estimated 3.5 million North
Americans suffer annually from this disease. In a percentage of
primary CDAD patients, the disease can recur after the first
instance is successfully treated. This recurrent form is thought
to affect approximately 700,000 individuals per year in North
America. In most cases of recurrent CDAD, available therapies are
of limited value and in many cases, the prognosis can be poor. It
is widely accepted that there is a clear unmet medical need for a
treatment of the recurrent form of 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. As well
as SYNSORB Cd(R), SYNSORB Pk(R) is also 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 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 affiliated companies and SYNSORB's
carbohybrid program.
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 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.
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FOR FURTHER INFORMATION PLEASE CONTACT:
The Equicom Group
Jason Hogan
Investor Relations
(416) 815-0700 ex 222
(416) 815-0080 (FAX)
United States: 800-385-5451
jhogan@equicomgroup.com
or
SYNSORB Biotech Inc.
Cindy Gray
Investor Relations
(403) 270-1315
(403) 283-5907 (FAX)
synsorb.com
or
SYNSORB Biotech Inc.
Mr. Doug Froom
Vice President Business Development
(403) 283-5900
(403) 283-5907 (FAX)
dfroom@synsorb.com
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