Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

I thought it might be beneficial to our communal mental health to have some diversion from constant bickering over the fate of prurisol trial, the degree of criminality in Leo's acts (or should I say Acts of Leo) etc. So, here is what I currently know about drug candidates for treatment of severe oral mucositis.


Some comments.

SOM Incidence Rate:
1.The inclusion threshold for cumulative radiation dose into oral cavity varies between trials: For Brilacidin and Dusquetide it was 55 Gy, For GC4419 it seems to be 50 Gy, and no reported threshold for the rest.

2. In case of GC4419 the comparative values to others are reported as last RT, or thru last radiation treatment – thru 60 Gy is Galera's invention for per protocol analysis.

SOM Duration:
1. In general duration numbers as they are currently reported fall well short of useful. This is amply demonstrated by values for Brilacidin and GC4419. When incidence rate is below 50 % then median duration per ITT is bound to be ZERO - effective reduction of incidence masks what is happening with duration. It would be far better if durations (median and mean) were reported per number of subjects experiencing SOM.
And that brings up the question: What the hell Galera is reporting? It can’t be median duration per ITT because: A. Incidence rate is below 50 % B. Non-zero median below 3 days is highly questionable, because the typical minimum number of days between SOM evaluations is 3 days. I suspect Galera is reporting average duration of SOM per ITT. In that case average per subject experiencing SOM would be 4 days – and that makes sense.
It Would have been nice to see Galera report onset and duration also thru last radiation treatment. But one can apply ‘TIAB’s principle’ here – delayed or omitted values mean bad or at least worse than reported.

2. That stupefying 3 days median duration of SOM with placebo reported for Brilacidin trial is a reflection of low incidence rate (60 % which is bested only by Galera’s thru 60 Gy group) and low number of subjects – the subject with 3rd lowest duration of SOM happens to be the median subject in prurisol trial's placebo group and he/she shares the duration value with the subjects having 1st and 2nd lowest durations, at least.

Feel free to draw your own conclusions.