No therapeutics based on live viruses have ever been approved by the FDA. Even modalities such as gene therapy which have been under development for 2 decades has not been able to gain approval. This company will have a long road to hoe. If anyone is aware of relevant precedents by FDA though, please share.
The FDA gave us a special protocol assessment (SPA) for our phase 3 head and neck trial.
An SPA should eliminate most of the ability of FDA statisticians to nitpick about the design of the trial. In many FDA briefing documents, we see long rationalizations by FDA staffers as to why a particular clinical trial did not measure what it was supposed to measure. Under an SPA, the FDA enters into a written, binding agreement that the design of the trial is sufficient to demonstrate an agreed-upon set of clinical endpoints.
In general, the idea is if you sign an SPA with the FDA and conduct the trial as agreed, good results from the trial will be sufficient for marketing approval. This makes securing an SPA especially valuable to both the company and its investors.
You are correct no live virus has yet been approved. It could be a lot longer if Reolysin was an engineered virus, it is not. The reovirus proprietary formulation of the Dearing 3 strain is trademarked as ‘Reolysin’ by Oncolytics Biotech (ONCY). Dearing 3 reovirus is non-pathogenic (does not cause disease in humans). The average adult has already been exposed to the virus and exhibits some reovirus antibodies. From 70% to 100% of various adult population are exposed to the reovirus already. The real issue is the human immune system not the FDA. If trials prove more than a little statically efficacy along with the known safety profile approval will come within the normal timeline for a first of class oncolytic treatment IMO.