Replies to post #229848 on Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

I Agree. It looks like Brilacidin and GC4419 are about equally effective. Galera's thru 60 Gy is a brand new per protocol category invented by Galera, ignore it. GC4419 full radiation treatment numbers probably get some additional shine from

1. including subjects with slightly lower cumulative radiation dose than was the case with IPIX, 50 Gy vs 55 Gy and
2. allowing the use of certain antifungal treatments, if the trial protocol was unchanged from the one used during phase I.

For full 7 week radiation treatment
Incidence rate GC4419 : 43.4 %
Incidence rate Brilacidin: 42.9 %
Median time to onset GC4419: 61 days
Median time to onset Brilacidin: > not reached
Median SOM duration GC4419: 1.5 days
Median SOM duration Brilacidin: 0 days

Correction to my earlier statements (I ignored the possibility of censoring until now - so stupid):
It seems to me that GC4419 medians [see 1 below] involve substantial censoring before trial day 60. The reported incidence rate of 42.9 % does not allow for any sort of median time (per ITT) unless censoring is present. For comparison, Brilacidin trial had 1 censor before day 60.

[1] GALERA insist that they are reporting medians. I have my doubts about the duration of 1.5 days. But that is minor. As a whole reporting of SOM trials is an art form I have not encountered before.

That said, the major difference between GC4419 and Brilacidin is the method of administration where Brilacidin has a clear advantage. Issue of tolerability may be another where Brilacidin has distinct upper hand - censoring hints into that direction. But, things can change, if GALERA can show, as it is aiming to do, that GC4419 will also reduce cancer recurrence rates. GC4419 converts radiation created superoxide to hydrogen oxide which is, supposedly, not well tolerated by cancer cells. So far no evidence of rate reduction based on phase I trial. It is too early to say if p2 is showing anything.