Replies to post #104513 on Innovation Pharmaceuticals Inc (IPIX)

[daydreaming2]

My biggest query is how cute did those little hamsters look with them tiny cups swishing their mouths out, for the trials!?

[thefamilyman]

It will "turn out" to be successful. My logic is simple. Brilacidin has already been proven safe and efficacious in humans. B-OM has already worked in the animal model of OM. There is no reason to believe that B-OM will not work in humans just like it did in the animal model. Therefore my confidence is very high.

But when all is said and done, that is still JMHO.

Any guesses on how this B-OM trial outcome may turn out? Anyone have a logical reason why the trial results will be or not be what we are looking for.
-believer20

[biodoc]

believer20, I am very optimistic about B-OM. Here's why:

(1) Pre-clinical data is most impressive. In acute radiation model and fractionated radiation model, duration of oral mucositis was decreased by >90% when animals were treated 3x daily for 28-35 days. Animals also had greatly decreased severity of oral mucositis in these studies.
Pre-clinical data

(2) With Brilacidin-OM, Cellceutix is exploiting the anti-inflammatory and anti-biofilm properties of Brilacidin to protect oral mucosa from the insult of chemoradiation. This may be confusing for investors who have only focused on Brilacidin as an anti-bacterial. The anti-bacterial properties of Brilacidin may play a role in limiting further tissue damage but again, the focus is on Brilacidin's anti-inflammatory and anti-biofilm properties that will provide an ongoing 'protective coating' for the oral mucosa for the duration of chemo/radiation.

(3) The design of the clinical trial with an oral rinse 3x per day for up to 7 weeks is ideal. The entire window of potential mucosal tissue damage related to chemoradiation is covered. Chemo/radiation is an on-going insult to tissues and mucosal linings need protection before tissue is damaged and throughout the period of potential tissue destruction from chemo/radiation.

My expectation is that most patients will still have some degree of oral mucositis but the severity and duration of oral mucositis will be greatly decreased. Though the trial is blinded, I think it will be very easy for the investigators to tell who is getting B-OM and who is receiving placebo. Also, the reason Cellceutix is able to go against placebo is because many other attempted prevention efforts/treatments for oral mucositis have had such limited effect that they really aren't much better than placebo. The bar is actually very low for this terrible condition where nothing really works.

I've posted on this topic before 84092;99596,