Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

Farrell90. I was trying to make a point why DeGrado is a good person to have onboard, be it in exchange of letters with FDA or in actual meetings. Now about he numbers

From Polymedix presentation:
paraesthesia
1. dose- depended; reported at ≥0.3 mg/kg in 60-100% of subjects
2. mild to moderate in intensity
3. resolved without treatment within 3 to 9 days

Cellceutix phase IIb trial dosing 0.6 mg/kg to 0.8 mg/kg. about 60 % of subjects with numbness or tinging (paraesthesia). However, no treatment related SAEs.

Using 70 kg skinny body weight and 4 to 5 liter large blood volume Cellceutix dose numbers translate to range 8 - 15 uM (if web calculators work correctly). Leo stated that IC90 in human lung cells is in low uM range.
Conclusion: FDA may want to discuss about paraesthesia. Does that mean they are willing to reject Brilacidin? Hardly!

Some sources:
Short discussion about paraesthesia as it relates to brilacidin
https://www.businesswire.com/news/home/20110512005450/en/PolyMedix-Presents-Clinical-Pre-Clinical-Data-PMX-30063-Defensin-Mimetic

Cellceutix presentation that covers dosing in both Brilacidin trials.
https://static1.squarespace.com/static/5715352e20c647639137f992/t/583f8286d2b85731b8713a36/1480557192947/A-Randomized-Double-Blind-Study-Comparing-Single-Dose-and-Short-Course-Brilacidin-to-Daptomycin-in-the-Treatment-of-Acute-Bacterial-Skin-Skin-Structure-Infections-ABSSSI1.pdf

conversion calculator:
https://www.graphpad.com/quickcalcs/Molarityform.cfm