Synsorb Pk With Antibiotics Effective In Prevent Serious E. Coli Infections
Calgary, AB -- Nov. 25, 1998 -- Study results, presented at the 28th eastern
regional meeting of the Japanese Society of Nephrology, show that Synsorb
Biotech Inc.'s Synsorb Pk (TAK-751S in Japan) co-administered with
antibiotics was considered to be safe and effective in preventing the development
of serious complications from enterohemorrhagic E. coli infections, such as
hemolytic uremic syndrome (HUS).
The study was part of a global effort focused on the development of Synsorb Pk,
the first and only product being tested in clinical trials to treat pediatric
Enterohemorrhagic E. coli (EHEC) infections (including E. coli O157:H7).
Dr. Hiroshi Ito, principal investigator, presented the results of the study which
was carried out in Japan from June 1997 to February 1998.
Initially, 128 children aged six months to 15 years with symptoms of EHEC
infection were enrolled in the trial. The study's final analysis included only those
children who were confirmed to have EHEC and were admitted to hospital
within four days of the onset of symptoms.
The researchers reported that 85 of the 128 children were confirmed positive for
EHEC, but only 68 were enrolled within four days of the onset of symptoms. Of
these 68 evaluable patients, four (5.9 percent) progressed to HUS. However,
three of these four patients did not complete the required course of treatment.
The researchers confirmed that of the 65 EHEC positive patients who completed
the required treatment course, only one (1.5 percent) progressed to HUS.
Previous Japanese studies of EHEC patients treated with antibiotics alone
reported a rate of progression to HUS of 15.7 percent.
A secondary outcome analysis was also performed which analysed the toxin
levels in the patients' stools before and after the administration of Synsorb Pk.
The researchers reported that even high levels of free toxin in the stool decreased
to below detectable limits after the first day of treatment with Synsorb Pk.
Additional stool analysis confirmed that the toxins were absorbed by the Synsorb
Pk.
Synsorb Biotech Inc. is presently conducting a double-blind, placebo-controlled
phase III clinical study of Synsorb Pk in Canada, the United States and
Argentina. This pivotal trial is examining the utility of Synsorb Pk without
co-treatment with antibiotics in reducing the progression to HUS in children 15
and under. |
