Replies to post #120435 on Innovation Pharmaceuticals Inc (IPIX)

[cabel]

Thanks for that detailed post,... enlightening to say the least!

[chrisrobert]

Thank you, great post and helps with setting reasonable expectations regarding time frames for results. Much appreciated.

[MinnieM]

It looks like this is the big question with the Brilacidin-OM trial:
https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=3

Detailed Description:

This study will examine whether daily oral rinses with a solution containing brilacidin will prevent the occurrences of OM or lessen the severity of OM if it occurs. Patients will use an oral rinse 3 times daily for up to seven weeks during chemoradiation for head and neck cancer.

Hopefully, we see a reduced % of cases of OM in the Brilacidin arm along with fewer severe cases.

Welcome to the board.

[Amatuer17]

Good post - your assumptions are good.
In fact I suspect that the recruitment may not be that easy as such Leo has so many sites. Conducting trials at multiple sites is an expensive proposition. I had read an article that explained the controls teams need to put to distribute the trial drugs to patients and entire logistics around it. As such pharma companies try to find centers where they can find maximum patients.

So your guess of 1 patient per site per 2-3 weeks may be more accurate. Hopefully Leo will give an update with 10-k on these numbers.

[frrol]

Good insights, sound right to me. Welcome to the board. Ignore the inevitable noise; there are good folks here who do appreciate objective, informed views.

Relatively speaking, the B-OM phase 2 is still going to be a quick trial.

[biodoc]

Outstanding, super well-informed post. You explained the design and challenges of the Phase 2 B-OM trial very clearly. Thank you.

On August 3 I sent a note to Dr. Alexander:
Dr. Alexander,

I very much appreciate what you and the Cellceutix team are doing to advance the pipeline. i am a long term investor with approximately xxxk shares.

A couple of Brilacidin oral rinse questions:

(1) It looks like enrollment opened at the first two sites about 9 weeks ago. Do you know about how many patients have been enrolled from these first two sites and if any have completed the 7 week treatment regimen?

(2) Reviewing the inclusion and exclusion criteria for the B-OM trial, can you give me an idea of about how many patients are likely eligible at each center over a 'typical' month? I am trying to get a read on how easy/difficult it is to find patients for what appears relatively stringent trial criteria.

Thank you very much.

And the appropriate somewhat vague response:

Dear Dr xxx
thanks so much for your email.
we are very excited that subjects are now enrolled in the OM study at two different sites and more sites are being activated in the next several weeks.
Our press release was mean to inform investors and the public of the beginning of subject enrollment and we plan to provide periodic updates in the future.
Actual subject enrollment at each site is dependent on a number of factors - including hospital location and size of the population. We have carefully chosen sites that should be able to enroll qualified subjects in the most rapid manner possible.

Best regards, Jim Alexander

So all I really know is that as of the 1st week of August, more than a couple patients were enrolled. It's interesting that we both used the term 'stringent' to describe trial inclusion criteria and you outlined the reasoning really well. I think this particular population has 90%+ incidence of severe (Grade 3,4) oral mucositis but my sources are somewhat conflicting.

I hope they can enroll one patient every week at each site but this might be overly optimistic. No basis for my opinion but I was thinking/hoping 1 or 2 a month at each location (your 2nd scenario). Perhaps Leo will give us a better read in the coming weeks.

Thanks again. Looking forward to your ongoing thoughts/comments.