Trial Strategy

It is easy for us to criticise the way Noxopharm is going about its mission, but we should at least acknowledge that the scientists and consultants working with NOX are more highly qualified than any of their critics.

I was reminded of this fact when brooding over the decision to use sarcoma as the fastest way to FDA approval, when it finally occurred to me that the company had made a strategic decision - to conduct two different types of pivotal trials in order to maximise market acceptance after approval.

Sarcoma will be targeted by Doxorubicin plus Veyonda. I had expected Veyonda plus radiation to be used in the first registration trial, but the reality is that chemo is an orthodox form of therapy with which oncologists are familiar. Noxopharm will have an easier time recruiting sarcoma patients if using chemo plus Veyonda than they would if using unorthodox treatment involving Veyonda plus radiation. As for trial design, it would pit Doxorubicin against Doxorubicin plus Veyonda, so the success hurdle will be low. FDA approval should lead to wide acceptance by oncologists, who could combine Veyonda with their favourite chemotherapy.

CEP-2 (Sarcoma) makes the case for Veyonda plus chemotherapy, which is the major form of cancer therapy.

DARRT-2 will make the case for Veyonda plus radiation. The trial design cannot be finalised until full data from DARRT-1 is known, so it makes sense to crack on with CEP-2.

Noxopharm has access to cash that is relatively expensive, but at least it is available. The terms are nearly identical to those agreed by Novogen when it raised cash after the RTO and involves one of the lenders from that successful transaction, so we can assume that the Board and their advisers know a bit more about it than we do.

Noxopharm's patent attorney has a history of success, their chemist has a number of issued patents in his name, Veyonda appears to be able to generate abscopal responses and to activate the innate immune system. There is no doubt that Noxopharm has missed some ambitious timelines, but not because of failure. Their problem is that they have had too much success. I can live with that.