Innovation Pharmaceuticals Inc (IPIX)

[KMBJN]

Subgroup analysis depending on cisplatin chemo dosing - either one big dose every 3 weeks or a smaller dose every week.

Previously, had:

mITT

placebo: 15/25 60.0%
brilacidin: 9/21 42.8%

PP

placebo: 12/20 60.0%
brilacidin: 7/19 36.8%


Now have:

mITT-cisplatin q. 3 wk

placebo: 10/14 71.4%
brilacidin: 3/12 25.0%

mITT-cisplatin q. 1 wk

placebo: 5/11 45.5%
brilacidin: 6/9 66.7%

PP-cisplatin q. 3 wk

placebo: 8/11 72.7%
brilacidin: 2/14 14.3%

PP-cisplatin q. 1 wk

placebo: 4/9 44.4%
brilacidin: 5/5 100.0%


Even smaller numbers, but shows statistical significance for prevention of SOM in subgroup getting cisplatin q. 3 weeks, but now more get SOM in subjgroup getting cisplatin q. 1 week...

Could be meaningless statistical noise, or perhaps brilacidin protects against the higher dose cisplatin, but not the lower dose cisplatin (spread out doses).


It seems that most people can't tolerate the big dose q. 3 weeks due to toxicity. Perhaps brilacidin can eliminate that severe OM toxicity in q. 3 weeks cisplatin, and allow more to get the more helpful dose: those patients getting q. 3 weeks have better outcomes (lower recurrence rates):

http://www.cancernetwork.com/head-neck-cancer/three-weekly-cisplatin-superior-weekly-dose-head-and-neck-cancer

However, another study showed q. 1 week more SAEs (including more likely to get severe OM), and no difference in locoregional recurrence rates, so need more information:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3564896/