Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

Scottsmith,
Yes, I walked back a little. Eventually there is too little exact information to make any reliable conclusions. My opinion of GC4419 hinges on one word "average". If GALERA really reported duration improvement based on average duration as described in one news report then GC4419 is very likely a great drug. But if the reported improvement is based on medians then GC4419 is still a good drug, but not much different from the others.

Galera's website is currently inaccessible (at least to my Chrome) but Google cache got me this:
Galera Therapeutics Reports Statistically Significant Results in a 223-Patient Phase 2b Trial of GC4419 for Severe Oral Mucositis in Patients with Head and Neck Cancer
• Achieved primary endpoint against placebo (p=0.024) demonstrating a statistically significant and clinically meaningful reduction of 92 percent in the duration of severe oral mucositis (SOM)
Secondary Endpoints Consistent with Primary Endpoint
• GC4419 reduced the incidence of SOM through completion of radiotherapy by 34 percent (p=0.009)
• GC4419 also achieved a 36 percent reduction in the overall incidence of SOM through 60 Gy of radiation (p=0.010)
• GC4419 reduced the incidence of debilitating Grade 4 oral mucositis (OM) by 47 percent (p=0.045)
plus:
As reported in December 2017, top-line results from Galera’s 223-patient, double blind, randomized, placebo-controlled Phase 2b clinical trial demonstrate GC4419’s ability to dramatically reduce the duration of severe OM from 19 days to 1.5 days (92 percent)

Then there is ffrol's find with some additional (interview?) information:
Patients in the placebo arm endured having severe oral mucositis for an average of 19 days, whereas the group of patients who received the 90-mg dose of GC4419 only experienced the side effect for about a day and a half – a 92 percent reduction.
Severe oral mucositis occurred in 58 percent of the placebo arm, but in only 40 percent of patients who received the 30-mg dose and 37 percent of those who received 90 mg.

Where did that word insert-text-here come from (this IS the only place it shows up)? Is it reporter added color (sentence looks like it), or not?

Summary of problems that make evaluation of GC4419 hard
- are we talking about averages or medians?
- no minimum or mean radiation dose reported
- lowest reported (with Validive) incidence rate in placebo arm may indicate lower mean radiation dose as was the case with Validive. The same goes with reported duration of SOM in placebo arm (if it is median).

Another thing to consider:
GC4417 is IV drug which adds logistics and cost complications to evaluation. I am not fond of putting a person into IV in order to prevent the person ending into IV.

Why I am so keen on average vs median? Well, average has one great advantage over median - if you know the average and number of subjects you can calculate a measure often called total patient/treatment time (ie. area under the curve). You can't do that with median and number of subjects, you need to know also the shape of the distribution. Insurance companies love averages for treatment durations because those enable them to create metrics (in their case - cost metrics) and compare various treatments. The same goes for me.

BTW: I took IPIX brilacidin PP Kaplan-Meier curves for incidence rates and multiplied populations, events and censors by 3 to get headcounts close to what GALERA had. Guess what:
Relative risk reduction is (still) the same as for GC4419 thru 60 Gy, 36 % and p value = 0.0020. But GC4419 would probably eat Brilacidin's lunch in SOM duration. But then there is that IV thing with its complications and additional risks. In sum: if both get approved there should be room for them both.

Cheap and unfair comparison, I know.