Oncolytics Biotech Inc T.ONC

New Press Release - Oncolytics Biotech® Advances Toward Registration-Enabling Trial for Pelareorep in Breast Cancer with Submission of Type C Meeting Request to FDA

Requested for Q2 2024, the Type C meeting is to focus on planned registration-enabling trial in HR+/HER2- metastatic breast cancerOverall survival results from the randomized HR+/HER2- metastatic breast cancer BRACELET-1 trial expected in H2 2024SAN DIEGO and CALGARY, AB, April 11, 2024...read article.

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From the perspective of oncology research, the announcement by Oncolytics Biotech regarding their upcoming meeting with the FDA signifies a pivotal moment in the clinical development of pelareorep for the treatment of HR+/HER2- metastatic breast cancer. The data suggesting a tripled confirmed response rate and a 50% improvement in median progression-free survival is particularly noteworthy, as it

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The strategic implications for Oncolytics Biotech and its stakeholders are significant. The anticipation of overall survival data from the BRACELET-1 study and the ongoing discussions with the FDA could potentially lead to a surge in investor confidence if the results are positive. This is especially true in the context of metastatic breast cancer, a market with a high unmet medical need and a

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Having a well-defined plan for the registrational track study will also help advance our strategic partnering discussions. We hope to meet with the agency in Q2 2024 and look forward to a productive dialogue. With anticipated overall survival data from the BRACELET-1 study and productive discussions with the FDA, 2024 is poised to be a transformative year for Oncolytics and our stakeholders."