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December 13, 2012
06:33 EDTONCYOncolytics Biotech announce positive top line Reolysindata for Phase III study
Oncolytics Biotech announced initial positive top line data from the first endpoint in its double-blinded randomized Phase III clinical study examining REOLYSIN in combination with carboplatin and paclitaxel in second-line patients with platinum-refractory, taxane-naive head and neck cancers. The endpoint examines initial percentage tumour changes between the pre-treatment and first post-treatment scans, typically performed at six weeks post-first treatment, of all patients enrolled in the study. The analysis was designed to assess early differences in response between loco-regional tumours and metastatic tumours, as classified and observed by the investigators. This is the first, and to this point only, endpoint to be un-blinded for this study.
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February 18, 2015
06:41 EDTONCYOncolytics Biotech completes enrollment of randomized Phase II study of REOLYSIN
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06:37 EDTONCYOncolytics Biotech completes enrollment in Phase II colorectal cancer study
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February 17, 2015
06:40 EDTONCYOncolytics Biotech receives ODD from FDA for REOLYSIN
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06:36 EDTONCYOncolytics Biotech granted Orphan Drug Designation for REOLYSIN by FDA
Oncolytics Biotech announced that the FDA has granted Orphan Drug Designation for its lead product candidate, REOLYSIN, for the treatment of pancreatic cancer. REOLYSIN is Oncolytics' proprietary isolate of the reovirus. Its primary mode of activity is to infect and selectively target tumours with activating Ras pathway mutations and/or over-expressions of Ras pathway elements including, amongst others, EGFR, BRAF and KRAS.
February 13, 2015
14:04 EDTONCYOncolytics Biotech treatment of pancreatic cancer gets FDA orphan designation
According to a post on the FDA's website, Oncolytics Biotech's treatment of pancreatic cancer, Reolysin, was granted orphan designation. Reference Link

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