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Tuesday, January 16, 2018 3:41:42 PM
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.
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