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Oncolytics Biotech® Receives Favorable Final Advice Letter from the European Medicines Agency for REOLYSIN® in Metastatic Breast Cancer
Oncolytics Biotech® Receives Favorable Final Advice Letter from the European Medicine...
About this update from Oncolytics Biotech Inc.
[{"type":"text","content":"\n\n\n\nOncolytics Biotech® Receives Favorable Final Advice Letter from the European Medicines Agency 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\n\n\n\n\n\n\nCanada NewsWire\nCALGARY and SAN DIEGO, CA, Dec. 5, 2017\n\n\n\n\nProposed phase 3 study design is found acceptable and can form the basis of a Marketing Authorization Application (MAA)\nFeedback continues to support our focus on HR+/HER2- patients that reported a statistically significant increase in median overall survival by nearly doubling from 10.8 to 21.0 months\nEMA advice consistent with feedback received from FDA paving the way for a global phase 3 study \n\n\n\nCALGARY and SAN DIEGO, CA, Dec. 5, 2017 /CNW/ - Oncolytics Biotech® Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN®, also known as pelareorep, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn 'cold' tumors 'hot', today announced that the company has received a favorable Final Advice Letter from the European Medicines Agency (EMA). The Letter refers to the proposed use of pelareorep in combination with paclitaxel, for the treatment of hormone receptor positive, HER2 receptor negative (HR+/HER2-) metastatic breast cancer patients in a pivotal phase 3 registration study and suggests that a single 400-patient study may be acceptable to form the basis of a Marketing Authorization Application (MAA) in Europe.\n\n\"The EMA's feedback and Final Advice Letter are very much inline with the feedback and advice we received from the FDA in September and adds to the support we have for our proposed target patient population of HR positive/HER2 negative metastatic breast cancer patients for the registration study,\" said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. \"Our statistically significant and clinically compelling overall survival data, Fast Track designation and clear guidance from the FDA and EMA allow us to focus on the completion of the adaptive study design that will incl...