A total of 177 patients were randomized and treated, of whom only 26 reached the milestone of one year post-treatment follow-up without disease relapse or progression, 14 of 95 patients (14.7%) in the perifosine and 12 of 82 patients (14.6%) in the placebo control group. No difference between treatment groups could be shown for local, loco-regional and overall disease control. Also the tumor response rate, as assessed after the end of the radiotherapy, was not different between the groups.
In contrast to the lack of an observed local effect, patients in the perifosine group, particularly the subgroup of patients who entered the study without prior chemotherapy, showed a trend towards longer survival than patients of the placebo control group despite the short duration of treatment (5-week course of 150 mg perifosine daily).
There were no safety signals that would lead to an amendment of the current safety data or risk benefit assessments of perifosine. The type and severity of side effects were in the expected range.
Marcel Verheij, M.D., Ph.D., lead investigator, "The neutral outcome of this study is related to the unexpectedly high number of distant failures and premature discontinuations for other reasons, which heavily compromised the power of the study to show any effect on the local control rate at one year."
Paul Blake, M.D., Senior Vice President and Chief Medical Officer at AEterna Zentaris,"In light of these neutral results and an unchanged safety profile, we can concentrate our efforts on the disease targets of both multiple m
|SOURCE AETERNA ZENTARIS INC.|
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