We have yet to treat our first patient with NOX66, but the clinical program has started. Splitting hairs? Perhaps, but starting any first-in-man study is an exercise in logistics. Getting a program of 5 clinical studies up and running is a considerable task.
We have cleared the major hurdles on all 5 studies: viz. manufacture of a trial batch of drug, selection of clinical sites, appointment of Principal and Associate Investigators, and agreement on the clinical protocol.
Two of the 5 studies also have been approved by the respective hospital ethics committees, the most time-consuming logistic in any clinical study. Once the final paperwork is received, both trials will open for recruitment.
As to why we are running 5 trials, it’s because we want to be in a position once we hopefully get proof-of-concept later this year, to go directly into registration studies ( to get marketing approval). And for that we need to know which clinical indications are going to provide the quickest and most assured route to market. Each of the planned clinical trials is asking a different question designed to provide that information.