Innovation Pharmaceuticals Inc (IPIX)

[djs7]

It will be interesting to see if BTD happens for IPIX BOM product which uses a simple 3X per day oral swish and spit.

A question concerning Galera's calculation for SOM duration reduction from 19 days to 1.5 days...relative to the Galera link you posted.

https://globenewswire.com/news-release/2018/02/28/1401167/0/en/Galera-Therapeutics-Receives-FDA-Breakthrough-Therapy-Designation-for-GC4419-for-the-Reduction-of-Severe-Oral-Mucositis.html

Did Galera use the calculation of MEDIAN duration or MEAN(avg) duration to get the SOM duration reduction days? They are not forthcoming in the above PR how they came about with this statistic. AND whether they included the zero day patients not getting SOM? Neither are they forthcoming with this info on their website.

If they are using the MEDIAN duration statistic (midpoint of SOM days) that includes patients with 0 days (NOT getting serious OM) in addition to the duration days for patients with serious OM, then it could be why this number is 1.5 days.

Here is a results link to Galera's Phase 1 of 46 patients for oral mucositis IV therapy including 6-7 weeks of therapy with 90 mg 1x per day and 5 days per week.

https://www.sciencedirect.com/science/article/pii/S0360301617340245

If you look under "Safety" titled paragraph and focus on the bar graph you will see the bottom section shows full Rx of 6-7 weeks for two seperate 90 mg dose protocols and a 30 mg dose protocol. There is an instance of Grade 3 SOM for est. 3 weeks, Grade 3 SOM est. 2 weeks (1 instance), Grade 3 SOM for est. 1 week (2 instances) and 6 instances of Grade 3 of est. 4-5 days.

Looking seperately at the 90 mg and 30 mg for 6-7 weeks of treatment. They are claiming under "Results" titled paragraph, a MEDIAN SOM duration of 2.5 days for 6-7 weeks of treatment. Are they including those patients who never got SOM and contribute 0 days when coming up with their 2.5 days MEDIAN duration calculation??

Hey look, I'm not knocking the product, I want to know what calculation Galera used to come up with SOM duration reduction that was presented to the FDA to get BTD. And why Galera is not indicating in their PR for BTD how they came up with 1.5 days SOM reduction for Phase 2 results (did they include all zero day patients not getting SOM and used the MEDIAN calculation?)

I want to see their Phase 2 results in a bar graph form similar to those in their Phase 1 results link I outlined earlier.

Only caught the following 46 patient results (Phase 1B/2A) on their website (similar to the article above).

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