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Oncolytics Biotech® Announces Successful End-of-Phase 2 Meeting with FDA for REOLYSIN® in Metastatic Breast Cancer
Oncolytics Biotech® Announces Successful End-of-Phase 2 Meeting with FDA for REOLYSIN...
About this update from Oncolytics Biotech Inc.
[{"type":"text","content":"\n\n\n\nOncolytics Biotech® Announces Successful End-of-Phase 2 Meeting with FDA for REOLYSIN® in Metastatic Breast Cancer\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n.prntac{\nTEXT-ALIGN: CENTER\n}\n\n\n\n\n\n\n\nCanada NewsWire\nCALGARY and SAN DIEGO, Sept. 18, 2017\n\n\n\nOutcome supports focus on HR+/HER2- patient group that reported an effective doubling of median overall survival from 10.8 to 21.0 months\n\n\n\nCALGARY and SAN DIEGO, Sept. 18, 2017 /CNW/ - Oncolytics Biotech® Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN® (pelareorep) a first-in-class, intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems, today announced a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for REOLYSIN in combination with paclitaxel, for the treatment of hormone receptor positive, HER2 receptor negative (HR+/HER2-) metastatic breast cancer (mBC) patients. The purpose of the meeting was to discuss the preclinical and clinical programs, including the design of the phase 3 registration study to support a future Biologics License Application (BLA) submission in the U.S. \n\n\"The FDA's feedback and positive End-of-Phase 2 meeting outcome support our proposed target patient population of HR positive/HER2 negative metastatic breast cancer patients for our registration study,\" said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. \"With statistically significant and clinically compelling overall survival data, Fast Track designation and now clear guidance from the FDA, we are focused on finalizing the adaptive study design that will include approximately four hundred patients with a pre-determined interim analysis. Importantly, the FDA provided guidance that if the study achieves its primary endpoint, then it will be the only study required for BLA approval.  The design of the study and this FDA guidance will also continue to drive our partnering process.\"   \n\nOncolytics' proposed target population for its phase 3 ...