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KMBJN

01/16/18 5:10 AM

#212974 RE: PlentyParanoid #212972

There is a paper out on Phase I results and found this audio of largest site from phase I at Iowa:

http://theoncologypharmacist.com/jhop-media-library/jhop-audiocast-library/16804-audiocast-severe-oral-mucositis-less-frequent-briefer-less-severe-with-use-of-gc4419

She talks about duration of SOM. I believe she said median decreases from 3-4 weeks to 1-2 weeks at most.

Agree that daily 1 hr infusion <1 hr before radiation is extremely patient unfriendly. AEs are increased nausea at higher dose and numbness of mouth during infusion. Most of her subjects were HPV+ oropharyngeal SCC.

I do think a rinse and spit more convenient for many subjects even if weekly IV infusion would be preferred for many who are worse off like my loved one who had pain doing anything mechanical in the mouth. Galera excluded those already using PEG tube.

Looking forward to seeing full results for brilacidin and Galera drug Phase Ii for comparison. They had more subjects and more impressive top line .. But poor subject convenience and more costly.

I don't see how reporting some measures of SOM duration would be a problem even if under 50% of subjects get SOM.