On June 8, 2015 Oncolytics Biotech reported an update on its planned registration program for REOLYSIN, its proprietary formulation of the human reovirus, at its Annual General Meeting of Shareholders (Press release, Oncolytics Biotech, JUN 8, 2015, View Source [SID:1234505378]). The presentation highlights that:
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The Company will initially focus on pursuing registration for REOLYSIN in two indications: the neoadjuvant treatment of muscle-invasive bladder cancer and the treatment of glioblastoma; and
The Company will determine further indications and treatment types in which to pursue registration subject to its receipt of data from ongoing single-arm and randomized studies with REOLYSIN.
"In determining our registration program, we have selected indications and study designs that rely on previous results from our existing preclinical and clinical program and will allow us to move into registration studies immediately after the completion of confirmatory run-in clinical trials," said Dr. Brad Thompson, President and CEO of Oncolytics.
Planned Registration Program for Muscle-Invasive Bladder Cancer
The Company has filed an Investigational New Drug Application ("IND") to conduct a small run-in study in patients with muscle-invasive bladder cancer. Pre-operative patients will be treated with a combination of gemcitabine, cisplatin and REOLYSIN and assessed for histopathological response and safety. Subject to confirmation of histopathological responses attributable to REOLYSIN, the Company intends to conduct a larger registration study in this indication.
Planned Registration Program for Gliomas
The Company recently announced that the IND containing the protocol titled "MC1472: Phase 1 Study of Replication Competent Reovirus (REOLYSIN) in Combination with GM-CSF in Pediatric Patients with Relapsed or Refractory Brain Tumors" was active. The Company intends to conduct a separate small run-in study combining the standard of care (surgery followed by radiotherapy and temozolomide) with REOLYSIN in adult patients. Subject to confirmation of responses, the Company intends to conduct a larger registration study using the better therapeutic regime.