A short note on the clinical data we presented at ESMO.
This is early data from our first-in-human clinical study, so it is important to keep that perspective. Over the course of the next 6 months we plan on reporting on this and other clinical studies at various international and local oncology conferences. Progressively, the clinical data will become more complete and more meaningful.
The current study is using patients with end-stage disease. Their cancers have stopped responding to all standard forms of therapy (radiotherapy and chemotherapy, including some of the latest immuno-oncology therapies).
We are asking two basic questions in this study:
- despite the highly resistant nature of their disease, can we still provide a meaningful anti-cancer benefit to these patients, to the extent that they live longer? And,
- can we achieve that in a well-tolerated way, hopefully by allowing the dosage of the chemotherapy to be cut by half?
The data, with the proviso of being early, suggests a tentative YES to both questions.
The design of this study means that patients spend 3 months on four different dosage combinations:
- Low-dose NOX66/Low-dose carboplatin
- Low-dose NOX66/high-dose carboplatin
- High-dose NOX66/Low-dose carboplatin
- High-dose NOX66/high-dose carboplatin
So, we are reporting here on the first (and lowest) of those dosage combinations.
It is encouraging, and noteworthy, that 4/5 patients who completed their 3-months of low-dose NOX66/low-dose carboplatin therapy, had no disease progression, with 1 of those patients still showing no disease progression after a further 3 months of high-dose carboplatin. And that this was achieved with no side-effects ascribed to the NOX66.
We don’t know, of course, to what extent this apparent arrest of disease progress is due to the NOX66 alone or to its sensitisation of the carboplatin. But at this stage, it really doesn’t matter.
What matters is that if this trend continues, particularly once we see the effect of a higher NOX66 dosage (with hopefully greater clinical effect), then we would appear to have something to offer the significant number of patients considered too old or too frail or too damaged by previous therapy to undergo further chemotherapy that might prolong their life.