SYNSORB Biotech Inc. Announces Outcome Of Interim Analysis of SYNSORB Pk Phase III
Trial
Wednesday, July 12, 2000 04:41 PM
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CALGARY, Alberta--(BUSINESS WIRE)--July 12, 2000--SYNSORB Biotech Inc. (Nasdaq:SYBB,
news, msgs)(TSE:SYB.) today announced the outcome of an interim analysis of the SYNSORB Pk(R)
Phase III trial, which was investigating the clinical efficacy of SYNSORB Pk(R) in preventing the
progression to Hemolytic Uremic Syndrome (HUS) in children suffering from E. coli infections (including
E. coli O157:H7).
In the overall patient population of 526 children treated within 5 days of the onset of symptoms, the
data showed a limited trend toward efficacy, and did not successfully meet the defined protocol
objectives.
However, approximately one third of the patients were treated within 2 days of the onset of their
symptoms and data from this sub-group of 152 patients demonstrated a statistically significant
(p<0.05) lower rate of HUS for SYNSORB Pk(R) compared to placebo. The rate of HUS was 7% for
patients in the SYNSORB Pk(R) group compared to 17% for the placebo group. The risk reduction of
developing HUS for SYNSORB Pk(R) relative to placebo was 59%.
"We are very excited to see statistically significant clinical data for SYNSORB Pk(R) in this sub-group
of children," said Dr. David Cox, President and CEO of SYNSORB. "The drug appears to offer
substantial benefit to patients when treatment is started during the first 2 days of their symptoms.
Given these results, we clearly need to consult with the regulatory authorities and other stakeholders
to determine how we can best capitalize on this valuable data and take full advantage of this
opportunity."
An independent assessment of the interim results was performed by a Data and Safety Monitoring
Committee (DSMC), comprised of third-party external reviewers. The DSMC confirmed the safety of
SYNSORB Pk(R) and concluded that there were no ethical or scientific reasons which would suggest
discontinuing the trial. However, given the findings in the sub-group, SYNSORB has determined that it
would not be appropriate to continue recruiting patients in the current trial until the Company has
engaged with the regulatory authorities to discuss options for concluding the program.
If further recruitment of patients into the trial is deemed to be necessary, the Company may seek third
party financial support. SYNSORB has consulted with existing marketing partners for SYNSORB
Pk(R), Takeda Chemical Industries Ltd., Paladin Labs, Inc. and Tramedico International BV, all of
whom agree with this strategy to determine the next course of action.
Verotoxigenic E. coli (including E. coli O157:H7) is recognized as the fastest growing foodborne
infectious disease in the world and is estimated to cause approximately 110,000 infections each year
in the US. Sources of the infection include contaminated meat, fruit and vegetables, unpasteurized
juice and milk, contaminated ground water, contaminated swimming pool water, and direct contact with
infected people or animals. The disease is a leading cause of both acute and chronic renal
insufficiency in children, and there is currently no treatment whatsoever for this disease, which can be
fatal.
SYNSORB Pk(R) 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(R) 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 is a Canadian-based pharmaceutical company dedicated to drug development and
manufacturing. In addition to SYNSORB Pk(R), the Company has a second Phase III product,
SYNSORB Cd(R) which has also been granted "Fast Track" designation by the FDA. SYNSORB
Cd(R) 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. |
