RE: Anybody know when a phase III trial is expecteGetting approval for a phase III pivotal trial requires the bureaucrats at the FDA saying “yes” to a viral therapy, Reolysin. Reaching the end point of a pivotal trial is a cause for celebration since commercial application becomes an overnight reality. If Reolysin, or any other viral therapy, gets out of control either by mutation or improper handling, it has the potential to cause harm. There are horror stories like Legionnaires’ Disease, outbreaks on cruise ships, thalidomide babies, etc that make bureaucrats paranoid about being responsible for saying “yes”. While the Brad whiners complain about the time to market, Brad is the CEO of a small Canadian development company. Persistence and breadth of application eventually lead to over 300 patients be treated. The positive trial results, without a back step failure, provided the FDA with the comfort level to approve the head and neck pivotal trial. It is interesting to note that head & neck is a small market opportunity where existing treatment offer little hope to the cancer victim. If Reolysin was a treatment for something less life threatening like acne or the common cold, I suspect Oncolytics would still be going through the motions of phase I and II trials until their funding dried up.
The important point is that the head &neck pivotal trial is the tip of the iceberg. Its success opens the door for the approval of pivotal trials for NSCLC, pancreatic cancer, colorectal cancer, ovarian cancer, …. Oncolytics is building an international pipeline to support these trials with each enrolment of a hospital in the head & neck study. Oncolytics has hospitals on board in the US, UK, Belgium and Canada, and is in discussion in other countries.