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Technology Stocks : SYNSORB (T.SYB)(SYBBF) CURE FOR CANCER? -- Ignore unavailable to you. Want to Upgrade?

To: Jim Oravetz who wrote (113)	7/6/2000 7:50:24 AM
From: Jim Oravetz	Read Replies (1) \| Respond to of 164

BW)-July 6, 2000-SYNSORB Biotech Inc. today announced that the Company has received the final SYNSORB Cd(R) Phase II analysis, the primary endpoint for which is the rate of recurrence of Clostridium difficile associated disease (CDAD). The results showed that 41.7% of patients on placebo experienced recurrence of CDAD after their initial episode, whereas only 21.9% of those receiving 16g per day of SYNSORB Cd(R) experienced recurrence. This represents a relative risk reduction of 61%. This strong trend in favour of the drug confirms the Company's September 1999 decision to move aggressively into Phase III clinical trials. "These final results confirm that the Phase II trial successfully met its objectives," said Dr. David Cox, President and CEO of SYNSORB. "When we originally designed the trial it was determined that a relative risk reduction of at least 50% would be considered successful, so we are pleased that in the final analysis the drug showed 61% at the higher dose. The Phase III trials are well underway and we look forward to reporting on our continued progress." Patients enrolled in the Phase II trial had already suffered at least one occurrence 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. Of the 86 evaluable patients in the study, 41.7% of patients in the placebo group demonstrated recurrence (10 of 24), 36.7% on the 8g/day dose (11 of 30) and 21.9% on the 16g/day dose (7 of 32), P= 0.116 for 16g/day vs. placebo. The risk reduction for recurrence of the high dose relative to placebo was 61%. The analysis also confirmed that there were no serious adverse events attributable to SYNSORB Cd(R). Results previously reported by the Company in September of 1999 were based on Phase II interim data available at that time. For the final Phase II data analysis reported today, a stringent definition of recurrence was applied which required patients to be both clinically diagnosed with recurrence as well as having a microbiological test documented to confirm it. Application of the rigorous definition of recurrence resulted in exclusion of a number of patients from the final analysis. This reduced the number of patients available for statistical evaluation and led to changes in the rate of recurrence but still resulted in a strong trend in favour of the drug. Future analyses planned for the SYNSORB Cd(R) Phase III trial protocol will utilize this more stringent definition and are aided by the availability of a rapid test kit now used in confirming a diagnosis of recurrence. The SYNSORB Cd(R) Phase III clinical trials are investigating the effects of the 16g dose versus a 24g per day dose, compared with placebo, at 120 sites. Enrollment is on target for this point in the trials and discussions continue with potential marketing and distribution partners for SYNSORB Cd(R) in key jurisdictions such as the US and Europe. Jim