No need to panic

Noxopharm and Kazia have two things in common: their drugs in effect have no competition. The only question is whether they work, to the satisfaction of the FDA.

GDC-0084 is targeting brain cancer, but only for that portion of patients who do not respond to TMZ, the best available therapy. This is a clever strategy in my opinion, because 0084 will eventually compete against a drug that is not expected to provide a meaningful benefit for newly-diagnosed GBM patients with unmethylated MGMT. These are early-stage patients and new drugs might provide competition before a registration trial can be conducted, but the difficulty of crossing the BBB makes this a small possibility. As TMZ is not expected to be effective in this sub-group of patients, the only question, really, is whether 0084 will provide a clinical benefit in a stringent clinical trial. The current Phase 2a trial should answer that question.

A Phase 3 trial for NOX66 will target end-stage prostate cancer patients who have failed every therapy. The prognosis for these men is dire, with metastatic cancer spread to the skeleton causing great pain; and Overall Survival expected to be about 6 months IIRC. NOX66 has two pathways to FDA approval: (1) increase PFS and OS by a significant amount; or (2) reduce pain by a significant amount. The 1200 mg data released recently suggest that both should be a slam-dunk.

As patients in a Phase 3 trial will have already failed everything. I expect the comparator arm to get palliative radiation alone. The treatment arm will also get palliative radiation, but it looks like they will also get NOX66 for the first two weeks, then monthly for a week at a time. As is the case with 0084, the comparator arm is highly likely to have a poor outcome. If the 1200 mg data is replicated in a larger trial – and the addition of NOX66 monotherapy should if anything IMPROVE those results – then a significant benefit for the treatment arm seems assured. For these reasons, I think Noxopharm should jump straight into a Phase 3 trial.

I think investors failed to appreciate the significance of the 1200 mg results, which were excellent. The sell-down of Noxopharm in recent days has provided a buying opportunity, in my opinion, one which I took.