REO 013 Brain is an open-label, non-randomized translational study of REOLYSIN® given intravenously to patients prior to planned surgery for recurrent high grade primary or metastatic brain tumours for one to five days in advance of their scheduled operations to remove brain tumours. Patients will be divided into two groups: Group A will be patients undergoing surgery for recurrent high grade primary tumours, while Group B will be patients with brain metastases from any known solid tumour type. Within each group, patients will receive treatment in cohorts of three, with the first three receiving a single infusion of REOLYSIN® on day 1 only, the second, on days 1 through 3, and the third, on days 1 through 5. Approximately 18 patients will be enrolled. The primary objective is to assess the presence of reovirus within surgical specimens taken of patients’ resected brain tumours. The secondary objectives are safety, humoral and cellular immune response to REOLYSIN® and to assess the replication and antineoplastic effects of reovirus in brain tumours.
At the 8th Annual International Conference on Oncolytic Virus Therapeutics in April 2014, Oncolytics collaborators presented early data from the study showing, for the first time, that an intravenously delivered oncolytic virus can cross the blood brain barrier to access tumours in the brains of humans. Further data presented at the ASCO Annual Meeting in June 2014 detailed the responses of the three patients who had completed the study to that date, including one with glioblastoma multiforme, one with grade 3 oligodendroglioma and one with colorectal brain metastasis. All three resected patient tumours contained wild-type reovirus RNA and protein. There was evidence for wild-type reovirus productive infection in two of the tumours.
Interim data presented by the Company at the 2015 Immune Checkpoint Inhibitors Meeting in March 2015 and the Royal Society of Medicine’s Immuno-Oncology: Using the Body’s Own Weapons Conference in April 2015 showed that REOLYSIN® induced the up-regulation of PD-1 and PD-L1 in patients for whom target tissue was available at the date of analysis, and that this up-regulation was strongly associated with productive reoviral infection.
The study is being sponsored by the University of Leeds.