Replies to post #251434 on Innovation Pharmaceuticals Inc (IPIX)

[georgejjl]

Brilacidin was more effective in decreasing the incidence of Severe OM in patients receiving the more aggressive chemotherapy regimen - cisplatin administered in a higher concentration (80-100 mg/m2), approximately every 21 days - as compared to lower concentrations of cisplatin (30-40 mg/m2) administered weekly.

· Reduced Incidence of Severe OM, 21-day Cisplatin Regimen subset

o Placebo 71.4%, reduced to Brilacidin 25.0% [mITT Population] (p=0.048).

o Placebo 72.7%, reduced to Brilacidin 14.3% [PP Population] (p=0.025).

· Delayed Onset of Severe OM, 21-day Cisplatin Regimen subset

o The time to onset of Severe OM was delayed with Brilacidin treatment compared to placebo, even more markedly in the 21-day cisplatin regimen subgroup.

http://www.ipharminc.com/press-release/2018/5/9/innovation-pharmaceuticals-concludes-data-analysis-of-its-phase-2-clinical-trial-for-severe-oral-mucositis-in-head-and-neck-cancer-positioning-to-fill-a-substantial-void-in-supportive-cancer-care

Good luck and GOD bless,

George

[PlentyParanoid]

I was thinking more along the lines IPIX interpreting cumulative radiation dose to be below 55 Gy, which was the exclusion/inclusion limit for mITT. Then FDA saying that it looks like above 55 Gy. Or rejecting subjects because of other protocol violations and FDA not agreeing.

Head count ratios cisplatin Q1W/Q3W for Brilacidin and placebo seem to indicate that Brilacidin Q3W group was subject to more rejections than others. Still, it would take a good and unlikely number of FDA reversals involving SOM subjects to bring response rate in cisplatin Q3W group above that reported for dusquetide. Also, it is quite possible that IPIX did not stratify by cisplatin schedule, in which case my comment is moot.