Replies to post #213057 on Innovation Pharmaceuticals Inc (IPIX)

[frrol]

Yes, Plenty. The mean duration of even the placebo arm looks somewhat short, you are not imagining that. And inferring the likely median that way is mathematically fine, but, ok....So what?

There is variability in these trials; we saw that on our very own trial, where our placebo arms incidence looked low. Fishy? Maybe. Or just variability.

I don't think there's anything "fishy" about their trial, nor ours. Just open questions.

Btw since the Galera site seems down I used this link: https://www.curetoday.com/articles/drug-shows-promise-in-reducing-oral-mucositis-in-patients-with-head-and-neck-cancer

[KMBJN]

GC4419 Phase I results are available here, with lots of useful information:

http://www.redjournal.org/article/S0360-3016(17)34024-5/fulltext

The authors (Carryn Anderson at Iowa, who gave the earlier linked audiocast on study results, is first author) in Table 4 give median SOM duration from previous Phase 3 trials, and say it was 22 and 26, and 26-30 (estimate) days for placebo. The 14 subjects receiving 6-7 weeks of 30 or 90 mg GC4419 had median duration of SOM of 2.5 days. Phase II placebo median duration of SOM of 19 days is a little lower than previous trials, but not outrageously so. 38 of 46 subjects in Phase I were oropharyngeal, most Stage IVa, mean age late 50s, and most HPV+ (25/27 tested, 19 unknown). Will see if similar population for their phase II study.

Interesting to note that Stephen Sonis is second author on the study - that guy has his finger in every OM trial and drug pie! He has lots of good publications:

http://www.dfhcc.harvard.edu/insider/member-detail/member/stephen-t-sonis-dmd-dmsc/

Including discovery of a novel peptide that worked well in animal models, amongst many others.

Glad to have him as a scientific advisor on our team, even if it seems he is on every team.

Looking forward to seeing full GC4419 and brilacidin Phase II results.