07:33 AM EDT, 10/04/2024 (MT Newswires) -- Oncolytics Biotech ( ONCY ) said recent clinical efficacy results from the BRACELET-1 trial in HR+/HER2- breast cancer are paving the way for a clinical study designed to support an accelerated approval.
Early next year, the company plans to submit to the FDA a pelareorep + paclitaxel combination therapy breast cancer trial. The study will enroll 180 patients with HR+/HER2- advanced/metastatic breast cancer that meet certain conditions.
Oncolytics also expects to continue developing pelareorep in gastrointestinal cancers and anal cancer.
Initial efficacy results from cohort 5 of the GOBLET study, which is investigating pelareorep in pancreatic cancer in combination with the chemotherapy modified Folfirinix with or without atezolizumab are expected in the second half of 2025.
Oncolytics was last seen up US$0.01, to US$0.94 in U.S. premarket trade.