Replies to post #253093 on Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"Both parties agreed to an acceptable Brilacidin Phase 3 development pathway, including studying Brilacidin oral rinse effects on SOM when cisplatin is administered in higher concentrations (80-100 mg/m2) every 21 days, and at lower concentrations (30-40 mg/m2) administered weekly as part of the chemoradiation regimen."
http://www.ipharminc.com/press-release/2018/12/17/innovation-pharmaceuticals-completes-end-of-phase-2-meeting-with-fda-brilacidin-oral-rinse-to-advance-into-phase-3-clinical-trials-for-prevention-of-severe-oral-mucositis

It seems like the objective is to run the same test, presumably with a larger sample size. IF the results are similar what would the FDA do?
Approve its use for patients about to undertake the higher concentration dosage for head and neck cancer treatment?
In that case and given that that is the current standard of care there is a sizable, defined market.
The argument has been made here that the real market is huge by comparison based on the off-label prescriptions likely to be written in the hope of preventing OM in any patient who MIGHT develop it regardless of their specific cancer, assuming a similar treatment regimen.

IF the results are similar don't they suggest that B would actually be contra-indicated (I think that's the right word) in patients undergoing the weekly lower concentration treatment, which inexplicably resulted in a HIGHER incidence of OM than the placebo? And wouldn't that put a large crimp in off-label prescriptions?
Or would the seemingly inexplicable nature of such a result perhaps jeopardize ANY approval? I'm sure no one EXPECTS a repeat performance but what would its impact be if it were to occur?



BTW, is it typical in a presentation such as the blog you linked (and which was used as a source for PP's extrapolations) to omit the data from a treatment arm when it doesn't meet an endpoint? (And am I using the right terminology in that question?) Frrol expressed this concern back in April: "This is going to attract unfortunate accusations of data mining" and I guess that's what I'm doing. Does the fact that the omission occurs in a blog make it acceptable in a presentation when it otherwise wouldn't be?

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

[BooDog]

Looking good Farrell90! Just waiting for the first deal.

[frrol]

Yes the FDA agreed there was possible signal in the Q3W arm, though the n was small, so it supported moving on to a Phase 3. The hope is that the BP is still interested. We don't know if they were waiting for BTD, as in "If the FDA gives B-OM BTD then we have a deal." (Was that the mentioned "DD"? Could be.) Our management has notably not said anything about the negotiations or term sheet since the BTD timeline expired in mid-Nov. We wait.

[PlentyParanoid]

farell90, no argument. Data for cisplatin every 3 weeks is very promising. I just wanted to point out that unclear results for weekly cisplatin are the likeliest reason for not granting BTD.

Thanks for the link to ASCO editorial, I have been looking for that kind of data. Now, does anybody happen to know treatment utilization percentages for cisplatin Q1W vs Q3W?