The first time you combine two drugs, it formally becomes a safety study and therefore Phase 1. Noxopharm added a wide range of efficacy end-points, so CEP-2 has two parts:
- Phase 1b - Safety and dose-finding
- Phase 2a - Looking for efficacy signals
With five trial sites involved, recruitment should be relatively quick. Noxopharm will want to see early signs that the combination is working, so tumor shrinkage and PFS will be important observations.
Noxopharm hopes to see a bidding war for the company, and the best way to do that is to generate compelling data.
It does not matter if this is Phase 1 data, providing it clearly shows superiority over standard of care. Nyrada, for instance, intends to sell or license its oral PCSK9 cholesterol pill
after Phase 1, providing world-best
in-vivo results are replicated in humans. Cholesterol is easily measured, so this time next year we could be looking at a deal that would be worth about $6.40 per NYR share for each $1 Billion involved.
Cancer is more difficult to measure, but Noxopharm is doggedly compiling a body of evidence that, in each case so far, has been superior to SOC. It would be naïve to think that this has escaped the attention of big pharma
