Oncolytics Biotech Inc. (NASDAQ: ONCY) announced it has reached alignment with the U.S. Food and Drug Administration on the design of a pivotal clinical study for pelareorep in patients with unresectable metastatic squamous cell carcinoma of the anal canal.

The agreement follows a Type C meeting with the FDA and establishes a framework for a randomized controlled trial that could potentially support both accelerated approval and full approval within the same study. The study will focus on patients in a post-standard-of-care population with no FDA-approved therapeutic options.

"While a single-arm study was possible in this setting, following a productive discussion with the FDA and in consideration of recent regulatory decisions regarding similar studies, we have aligned on a randomized controlled trial designed to potentially support both accelerated approval and full approval within the same study," said Jared Kelly, Chief Executive Officer of Oncolytics.

Squamous cell carcinoma of the anal canal affects more than 10,000 patients annually in the United States. Patients whose disease progresses following first-line chemotherapy and checkpoint inhibitor treatment currently have no FDA-approved therapeutic options.

In a recent study, pelareorep combined with a checkpoint inhibitor in second-line and later treatment achieved a median duration of response of 15.5 months compared to 9.5 months for standard care, and 12-month survival of 82% versus 45.7% for standard care.

The company plans to incorporate FDA feedback into the final protocol. Oncolytics is developing pelareorep as an investigational intravenously delivered immunotherapy agent designed to activate anti-cancer immune responses.

The information is based on a company press release statement.