Toronto, Ontario, Nov. 27, 2000 (Market News Publishing via COMTEX) -- Axcan Pharma Inc. ("Axcan") announced interim statistical analysis results of its Phase II study assessing the efficacy of the use of URSO(R) for the prevention of the recurrence of adenomatous colorectal polyps.
This one-year double blind placebo controlled Phase II trial involves 716 randomized patients and is being conducted in 17 clinical sites (3 in the US and 14 in Canada), under the guidance of Dr. Mark Larson (Mayo Clinic, Rochester, MN) and Dr. Robin McLeod (Mount Sinai Hospital, Toronto). The interim analysis was performed on 258 patients (121 on URSO(R) and 137 on placebo), who completed the one-year follow-up and who, at baseline, were all comparable in terms of demographics and polyps characteristics.
This interim analysis provides an indication of trends of efficacy of URSO(R) in the prevention of the recurrence of colorectal polyps. First, on average, the proportion of large lesions (greater than 1 cm) recurring after one year was twice as high in the placebo group compared to active URSO(R) (6% vs. 3%, respectively). Second, important observations were made in patients who had an early stage colorectal cancer at baseline. A polyp recurrence occurred in 44% of subjects receiving placebo, compared to only 25% among patients on URSO(R) (a 43 % decrease). Moreover, while the mean diameter of recurring polyps after one-year was 0.31 cm in the placebo group, it was only 0.07 cm in the URSO(R) study group.
"These trends are promising but they need to be confirmed by the final statistical analysis of the study, since they were observed in a small number of patients" said Dr. Patrick Colin, Vice President, Clinical Research at Axcan. They suggest that URSO(R) might have an effect on polyp recurrence and progression in patients who are exposed to the highest risk of colorectal polyps. These patients include those who had an early stage carcinoma at baseline. We also need to wait until the whole trial is completed to find out if URSO(R) can prevent polyp recurrence in all patients, whatever their risk of cancer," added Dr. Patrick Colin.
The clinical portion of this trial is expected to be completed at the end of the Summer of 2001. Final findings should therefore be available at the beginning of calendar 2002. |
