What is the time line? Seems the study would not be completed before the end of October if it takes 9 weeks of patient study. Have they enrolled enough patients to date? Nice release, but no information.
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.