SYNSORB Biotech Inc. Announces Exceptional Clinical Results for
SYNSORB Cd(R) in the Treatment of Recurrent Clostridium Difficile
Associated Diarrhea
CALGARY, ALBERTA--
Company also announces update on SYNSORB Pk(R) trial
SYNSORB Biotech Inc. ("SYNSORB") (TSE: SYB; Nasdaq: SYBB) today
announced that the Company has completed an interim analysis of
the Phase II clinical trial for SYNSORB Cd(R)as a treatment for
recurrent Clostridium difficile Associated Diarrhea (CDAD). Based
on the statistically compelling evidence of efficacy at the high
dose, SYNSORB intends to halt this trial immediately and initiate
Phase III trials as soon as possible.
Patients enrolled in the Phase II trial had already suffered one
recurrence of CDAD. All patients were treated with the antibiotic
metronidazole (normal first line treatment of CDAD) for the first
10 days, and were randomized to receive either a placebo, low dose
(8 grams per day) or high dose (16 grams per day) of SYNSORB
Cd(R), administered orally in powder form. Patients received
SYNSORB Cd(R) from days 1 through 25 and were monitored for 67
days. The trial originally envisaged the enrollment of 375
patients. The primary clinical endpoint was a 50 percent
reduction in the rate of recurrence of CDAD.
There were 103 patients enrolled at the time of this interim
analysis. Of all the patients enrolled in the trial, the rate of
recurrence was 48.3 percent for patients receiving placebo, 31.6
percent for patients receiving the low dose and 9.1 percent for
those receiving the high dose of SYNSORB Cd(R). In those patients
who completed an adequate course of metronidazole (10 days) as
co-therapy to the study drug, the recurrence rate was 63.6 percent
for patients receiving placebo, 48.0 percent for patients
receiving the low dose and 13 percent for patients receiving the
high dose. There were no serious adverse events attributable to
the study medication.
"We are extremely excited about the statistically compelling
evidence of efficacy at the high dose in this initial cohort of
patients," stated Dr David Cox, President and CEO of SYNSORB
Biotech. "The reduction in the CDAD recurrence rate is far in
excess of the Company's expectations and in excess of the 50
percent reduction the trial projected. This clinical trial has
shown us that the high dose should be used in future clinical
trials and we intend to move rapidly to initiate Phase III trials
with the high dose which will be the basis for our regulatory
submissions."
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 need for an effective
treatment for the recurrent form of CDAD.
SYNSORB also announces that it has completed a detailed review of
the on-going clinical program for SYNSORB Pk(R). In the spring of
this year, in consultation with the US Food and Drug
Administration (FDA) and the company's regulatory consultants,
SYNSORB began to plan a supplementary short term trial that would
test the utility of SYNSORB Pk(R) in treating verotoxigenic E.
coli (VTEC) gastroenteritis, (the early stages of E. coli
infections). Such a trial could have been completed relatively
quickly and would have provided for an accelerated New Drug
Application (NDA) filing for this minor indication, as early as
first quarter 2000. The hypothesis for the trial was that SYNSORB
Pk(R) might be expected to reduce the severity of E. coli induced
diarrhea. In further dialogue with the FDA, the agency gave
approval to commence this mini-trial but indicated that a single
study for the diarrhea indication would not be sufficient to
support a NDA filing, and should be supplemented by further
evidence. The Company examined many patient files for data
regarding severity of diarrhea collected during the main Hemolytic
Uremic Syndrome (HUS) trial. Subsequent analysis of these data
did not support the hypothesis that the drug will alleviate
diarrhea.
As a result, SYNSORB will not commence this short-term trial for
the supplementary diarrhea indication since the hypothesis is
unsubstantiated. The main HUS trial will continue to enroll
patients for the more important indication of HUS and is
unaffected by this decision. The Company will announce expected
completion of it's SYNSORB Pk(R) Phase III trial and NDA filing
date after further discussions with potential partners and the
regulatory authorities.
"While we are of course disappointed that we will not be filing an
NDA early next year for SYNSORB Pk(R) as originally planned, it is
fortunate that we have been able to discount the minor indication
of VTEC gastroenteritis before expending any resources on it.
Furthermore, several potential corporate partners had expressed
concern that if SYNSORB Pk(R) is approved for the 'diarrhea'
indication before the 'prevention of HUS' indication, it might
actually compromise pricing of the drug. Therefore we will
continue the main HUS trial to completion and file only for the
more significant 'prevention of HUS' indication," added Dr. David
Cox.
SYNSORB is dedicated to accelerated drug development from the
acquisition of promising compounds emerging from basic research
through clinical development, and ultimately to providing channels
to market for new discoveries. Headquartered in Calgary, SYNSORB
currently has two products in late stage clinical development.
SYNSORB Pk(R) is designed to prevent HUS resulting from VTEC
infections (including E. coli O157:H7). This disease is believed
to affect up to 40,000 people annually in North America. SYNSORB
Cd(R) is designed to treat recurrent antibiotic-associated
diarrhea (CDAD), a common hospital-acquired infection affecting up
to 700,000 North Americans per year. SYNSORB has additional
compounds in pre-clinical development, including the reovirus, a
potential cancer treatment being developed within its subsidiary
company, Oncolytics Biotech Inc., and novel antibiotics, with
inflammation and anti-virals targeted in the Company's research
and development 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.
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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)
or
SYNSORB Biotech Inc.
David Cox, Ph.D
President and CEO
(403) 283-5900
(403) 283-5907 (FAX)
or
SYNSORB Biotech Inc.
W. Douglas Froom
Vice President, Business Development
(403) 283-5900
(403) 283-5907 (FAX)
For product licensing information
or
SYNSORB Biotech Inc.
Cindy Gray
Investor Relations
(403) 270-1315
(403) 283-5907 (FAX)
synsorb.com
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