Innovation Pharmaceuticals Inc (IPIX)

[KMBJN]

Yes, trials discount subjects who don't receive the minimum cumulative radiation dose (typically 50-60 Gy of IMRT), since these subjects are less likely to develop severe OM.

https://clinicaltrials.gov/ct2/show/NCT02508389

Primary Outcome Measures :

Duration of Radiation Induced Severe Oral Mucositis per WHO Criteria, Through a Minimum of 60 Gy IMRT Delivered to the Tumor [ Time Frame: Minimum of 60 Gy administered to tumor, approximately 30 IMRT fractions, which is estimated to be 6-7 weeks. ]

They reported mITT, based on receiving mimimum 60 Gy, just like we are doing.

BTW, their drug reduced SOM incidence from 70% (placebo) to 46%.

and their drug required a 60 minute IV infusion every day before radiation

Brilacidin sure looks favorable compared to Galera's drug.