Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

On that I agree with you. I don't see any reason not to publish the meeting date. The time period to deliver meeting minutes and possible FDA responses is 30 days --> Leo seems to have enough fudge room without being coy about the meeting date.

BTW, eons ago my British educated (<-- caveat: snobbery possible) English teacher, when speaking about the proper usage of expression 'a few', defined it being more than 1 and less than 5. Where he got that one - no clue, but it has stuck.

In order to continue my tradition of being a verbose nuisance I put two tables below with these comments:
1. Numbers in the tables DO NOT present altogether fair comparison. Among differences: IPIX and Soligenix using radiation threshold of 55 Gy into oral cavity for inclusion into mITT. Galera and Amgen (palifermin) seem to have used 50 Gy. And there are others.
2. Galera has not specified what criteria was used in selecting base head counts for the reported percentages. CLEARLY IT IS NOT the number of randomized subjects (ITT) as Galera's presentation lets one to believe. As a results, head counts for Galera are too large in the tables.
3. In any case, forget Galera's GC4419, so far it has show more consistent results than Brilacidin. BTD was deserved.
4. IPIX seems to have tripped over the usual occurrence in their trials: placebo group behaving out of the norm. A trap that might have been avoided with a bit larger trial head count or maybe even doing things Galera's way - using 50 Gy threshold. That corresponds to 5 full weeks of IMRT out of max 7 and is obviously acceptable to FDA.
5. Soligenix got FDA's go ahead for phase 3 regardless of the miserable numbers with weekly cisplatin (worse than those for Brilacidin) and is recruiting, but accepting only subjects suitable to cisplatin Q3W schedule and cancer strictly in oral cavity. What might FDA think about brilacidin vs dusquetide?

Enjoy your weekend.

Placebo arms:


Treatment arms:


Sources:

Brilacidin:
http://www.ipharminc.com/new-blog/2018/9/24/brilacidin-for-oral-mucositis-at-a-glance-comparative-data-presentation-with-other-investigational-om-drugs

GC4419:
https://www.mascc.org/assets/2018_Meeting_Files/Fri29/Strauss_3/1411_Anderson_Strauss%203_Fri.pdf

Dusquetide:
WARNING: direct download of supplemental word DOC, which happens to be the only place where Soligenix gives overall SOM incidence numbers.
https://ars.els-cdn.com/content/image/1-s2.0-S0168165616315668-mmc1.docx
The careless buffoon who created the SOM incidence table in the said above supplemental doc copied head counts for ALL subject into table for subjects with cisplatin Q3W schedule. Therefore, one needs to peek at results at ClinicalTrials.gov to get the correct numbers for cisplatin Q3W subjects:
https://clinicaltrials.gov/ct2/show/results/NCT02013050?term=SGX942&rank=2

palifermin:
http://ascopubs.org/doi/full/10.1200/JCO.2010.32.4103?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed
and
http://ascopubs.org/doi/full/10.1200/JCO.2010.32.4095?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed