Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

I Smell Fish Market. But start is with relevance.

Dear ffrol, HPV+ is not irrelevant if you compare GC4419 performance to drugs in other trials. HPV+ skews the comparison in favor of the highest HPV+ proportion.

Little backgrounder on SOM vs Radiation

SOM emerges when cumulative radiation dose in ORAL CAVITY (not on target) exceeds 40 Gy, incidence rate and intensity correlates with mean radiation dose > 50 Gy and maximum dose > 65 Gy. What little has been reported of duration seems to be this: longer durations are associated with doses exceeding 40 Gy, which sort of follows from the preceding sentence.

From Kepivance to GALERA

Head and neck cancer trials with Kepivance included subjects having cumulative radiation dose less than 50 Gy. Still, the trials had mean cumulative radiation doses 68 Gy and 60 Gy. Compared to these means GALERA's 60 Gy cap does look strange. But strangeness does not end here.

The Kepivance trial with 68 Gy mean radiation doses in both arms recorded also these facts: in the placebo arm the median duration of severe OM for intent-to-treat population was 26 days, and for subjects who had severe OM the median was 37 days.

Now, Your 'find' purports that in GALERA's trial the mean calculated for placebo subjects with severe OM is 19 days. Really?

Median to mean ratio for exponential distribution is Ln(2) or about 0.7. OM duration distributions usually have fatter tails that exponential distribution i.e. the ratio is even less. Let's use Ln(2) as upper limiting factor for median to mean ratio.

We can now calculate the upper limit for GALERA's median duration for subjects with SOM in placebo arm: 0.7 * 19 = 14 days. Whoa! At least 62 % improvement over median for subjects with SOM in placebo arm of Kepivance head and neck trial. And more than 46 % improvement when compared to median calculated over ITT.

You can interpret the upper limit value in several ways
1. Subjects in GALERA's trial were very, very, very though
2. Something else is at work in the trial, and administered at least to placebo arm. Probably also to experimental arm.
3. Mean radiation dose across GALERA's trial is really measly
4. Or the usual: Fish Market

Enjoy.