DEP Enrollment Update, page-31

As someone said here a year or two ago, phase 1 of clinical trials is to determine if the treatment is safe enough to proceed and the dose limitations which should be applied.

Phase 2 is to determine efficacy, (does it work?) Here we have the puzzle, SPL seems to be trialling its DEP drugs against a wide range of solid tumours, not only that, but also in combination with other drugs. This has been referred to previously, as a rabbit hunt.

This means that the number of patients in any of these trials who have similar conditions and are being treated with the same DEP medicines is actually quite small. A lot less than the number in any of the three trials.

So the results may not be straightforward to interpret. It is perhaps worthwhile to recall what DEP drugs are supposed to provide:

- lower toxicity,
- greater solubility, improved action in the case of Irinotecan,
- better pharmacokinetics (as in greater concentrations in the tumours)

This trial is about better delivery of a known chemotherapy to deliver better efficacy. So maybe the broad approach is justifiable.

But it would be nice of this was explained, wouldn't it?