At our Annual General Meeting in June, we announced that we would be doing our first registration study of REOLYSIN® as a neoadjuvant in patients with muscle-invasive bladder cancer.

At the time, Brad Thompson, President and CEO of Oncolytics, explained, '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.'

What is a Registration Study?

A registration study is a randomized Phase 3 trial designed and run to generate the data necessary to apply for product approval. Generally speaking, a great deal of information about the drug has already been obtained in smaller, earlier-phase studies - for example, possible benefits and side effects, and whether there is a maximum tolerated dose. However, safety and efficacy, as compared with the existing standard of care in a given indication, must be confirmed in a larger patient population prior to seeking approval from regulatory authorities.

Why was Muscle-Invasive Bladder Cancer selected for this study?

  1. Anti-tumour effect as a registration endpoint: REOLYSIN®'s most consistent results shown thus far have been at reducing tumour burden - we've had good anti-tumour effects in all of the types of solid tumours we've treated to date.
    • Bladder cancer is the only cancer indication so far in which the FDA has accepted anti-tumour effect (measured histopathologically) as a registration endpoint.
  2. Fast results bring us closer to product registration: Neoadjuvant use of REOLYSIN® means that the study will be completed relatively quickly - each patient will be assessable for response no later than 9 weeks after first starting treatment.
    • The quicker the study is finished, the sooner we can apply for product registration (assuming that results meet our endpoints)

About Bladder Cancer

Bladder cancer is the sixth most commonly-diagnosed cancer in the United States, with the muscle-invasive variety being likely to spread to other parts of the body and recur. Treatment, therefore, is usually aggressive. Current treatment options involve surgery (removal of the bladder) and/or chemotherapy and radiation, though these methods only result in moderate survival outcomes.

Next steps for our Muscle-Invasive Bladder Cancer Registration Study

As we announced at our AGM, we've already filed the Investigational New Drug Application (IND) for a small run-in study in patients with muscle-invasive bladder cancer. Under the IND, pre-operative patients will be treated with REOLYSIN® in combination with the chemotherapy drugs gemcitabine and cisplatin, and then assessed for histopathological response and safety. Our preparations are now underway for the study to begin. Subject to the run-in studying confirming histological responses that can be attributed to REOLYSIN®, we intend to continue into a full-sized registration study for patients with muscle-invasive bladder cancer.

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