Oncolytics’ Phase III borrows adaptive design in SPA trial

Source: www.bioworld.com Author: Catherine Hollingsworth Oncolytics Biotech Inc. reached agreement with the FDA on the design of a Phase III trial of Reolysin in head and neck cancer, marking the first such agreement for an intravenously administered oncolytic virus. The Phase III trial will be conducted in two stages and will cost an estimated $15 million, Matt Coffey, Oncolytics' chief operating officer, told BioWorld Today. The Calgary, Alberta-based company has the cash to get through the first half of the study on its own, but it hopes to secure a partner to take Reolysin the rest of the way, he said. The trial uses an adaptive design in which "the endpoint is not fixed going in," CEO Brad Thompson said during a conference call. He said it was "a major advantage" getting the FDA to sign off on the study design up front under a special protocol assessment. Thompson said that the adaptive design already is in use in the area of infectious disease, and he said he believes that there will be "a big push" by the FDA for more adaptive trials to be conducted in oncology. The trial will assess the intravenous administration of Reolysin with the chemotherapy combination of paclitaxel and carboplatin vs. chemotherapy alone. The drug likely will be studied in about 275 patients whose cancer has progressed while on or after prior platinum-based chemotherapy. The first stage of the trial is nonadaptive and is designed to enroll 80 patients. The second stage is adaptive, and [...]