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Date: 2009-12-16
Phase: II
Anouncement: Result
Biotech: Antisoma (UK)
Product: AS1411 (aptamer binding to nucleolin, protein which is found on the surface of cancer cells)
Disease: metastatic renal cell carcinoma (kidney cancer)
Other: Antisoma announces that results of its phase II trial of AS1411 as a second-line treatment for metastatic renal cell carcinoma provide further evidence that the drug has anti-cancer activity.
Safety findings suggest that AS1411 is exceptionally well tolerated compared to most current cancer treatments. Data from the trial will be submitted to a forthcoming scientific meeting.
Antisoma had two aims for this study. One was to decide whether to continue development in renal cell carcinoma; the second was to inform development in other cancer settings. With respect to renal cell carcinoma, the AS1411 phase II data have been evaluated in the context of findings from a recent phase III study of the new drug everolimus. Independent assessment of scans from the AS1411 trial suggests single-agent activity comparable with that of everolimus, although the median progression-free survival was slightly inferior. Given the approval of everolimus earlier this year and the many other drugs now available for renal cell carcinoma, Antisoma does not plan to pursue development of AS1411 in this setting.
With respect to broader development, the AS1411 phase II trial in renal cell carcinoma provides further evidence of anti-cancer activity and a highly favourable safety profile.
These observations support previous findings suggesting that AS1411 has potential in various cancers. For the immediate future, development will remain focused in acute myeloid leukaemia. A randomised phase II trial in this setting reported positive data earlier this year (See clinical_studies)
A phase IIb trial in this indication will begin soon.