1. The standard dox trial to get tumour concentrations could easily have already been done. All you'd need to do is find a patient or two who are about to have naked dox and ask them whether they'd mind a biopsy or two, you know... in the name of science. There would be no need to do it in parallel with the AVA trial.
I expect naked dox concs. to be part of the package of data released in Q4.
Lots of people are currently being given Dox for their cancers, unfortunately. I'd bet plenty of them would agree today to a biopsy to try to find out how much dox is actually in their tumour environment, since it would be in the aid of research into a new cancer drug. It isn't exactly like anyone is trialling a novel drug. No special permissions from the FDA etc would need seeking. There is surely no need to wait until the MTD is found in 1a for the dox arm of the 1b study to be carried out. My money would be on that it has been done/has been started already. Are Avacta already sitting on data that show safety and how much dox 6K releases compared to the base drug?
It makes me expect that one morning there will be an RNS saying that due to ethical reasons the trial must be stopped. As must the usage of naked dox.
There is rarely good news when it comes to cancer.
My sister is a radiotherapist. She tells me that the general rule of thumb is that many men die with prostate cancer, but very few die of prostate cancer.