Oncolytics Biotech Announces End-of-Phase 2 Meeting with FDA

Oncolytics Biotech (TSX:ONC; OTCQX:ONCYF) shared the results from a positive End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) for REOLYSIN in combination with paclitaxel.
As quoted in the press release:

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.
“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.

Click here to read the full press release.

Source: www.newswire.ca