Replies to post #196731 on Innovation Pharmaceuticals Inc (IPIX)

[cabel]

Looks like the scientific posters here were right,... Interim Results are not a straight forward thing especially in double blind trials!!

[scottsmith]

Wow! Thanks for sending along. This means no interim Prurisol update?

[Amatuer17]

Well well
As the CEO he knows what to do and as investors who try to find meaning from each word - we can complain and criticize.

This again proves that even if he said few times in PR and conf about interim results - he can change his decision any time and any minute and no one can do anything.

[oddone33320]

It does seem improbable for Q3 based on that response - However, enrollment wasn't going to be complete until 9/1 based on the PR and 6 weeks of treatment after that is between 10/13 and 10/16.

Could they be waiting until ~6 weeks after the final patients were enrolled/started treatment to begin an "un-biasing" 6 week interim look? That could potentially allow for an interim results PR somewhere in late October, early November.

"The final number of patients will be up to 199, including those awaiting final screening test results through the end of this week (September 1). "

https://finance.yahoo.com/news/innovation-pharmaceuticals-completes-full-patient-110000597.html

[biodoc]

Thank you cabel. I sent an article to Leo on August 6 discussing situations where release of interim data is appropriate. I also addressed my concerns about potential bias. I am pleased that the company adapts.

[Blues44]

Exactly what point I was trying to make by noting the article. And as noted prior, interim analysis could lead to investigator/trial-subject bias. It also could result in needing a "stronger" P value and, as a result, the need to add more trial subjects. Thanks nerby for posting Mr. Erlich's response to your query.

[sox040713]

Good to know most patients have completed the study at this time. I expressed my concerns to Leo about releasing an incomplete interim analysis (< 100% of patients) as it could send mixed signals. I'm glad he's reconsidering. Thanks as always for sharing!

[frrol]

Not what you want to hear (slow recruitment, change of mind on interim results) but biotech requires patience, and optimism. Let's hope P is working. Perhaps we'll get top line results before year end. B-OM coming up next I guess.

[MinnieM]

It’s not surprising to me if we don’t get interim data from Prurisol even though we got them from Brilacidin OM. There are some key differences I’ve noticed after going back and looking at pr’s today regarding the OM trial vs the response you got from Leo regarding the Prurisol trial.

“Our plan was to to do an interim analysis of patients who completed week 6 and look for a signal.”

Prurisol 2b is a twelve week trial. https://clinicaltrials.gov/ct2/show/NCT02949388?term=cellceutix&rank=5

Brilacidin OM is a seven week trial. https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=3

Based on company pr’s, the Brilacidin OM trial needed the interim to support data showing anti-inflammatory properties to justify adding more trial sites.

http://www.ipharminc.com/press-release/2017/4/8/cellceutix-ceo-discusses-brilacidin-following-interim-trial-results-exceeding-expectations-for-treating-oral-mucositis-and-inflammatory-bowel-disease?rq=interim%20oral%20mucositis

“Cellceutix has moved through this trial methodically, waiting to increase trial sites to conserve capital until research provided additional support to the potential of the anti-inflammatory and immunomodulatory properties of the drug candidate.“

The Prurisol trial doesn’t need interim data to show effect on psoriasis. It already had a ph2a for that purpose.

The trial was slow in recruiting and they had to add a lot of trial sites. I’m not sure, but, it appears to me that by the time they had a high enough percentage to do the six week interim, there were too many that had already completed the trial due to the addition of so many new sites. I don't understand trial design as well as I'd like and I'm simply going by pr's coupled with the reply from Leo posted on the board today.

The key difference I see in giving interim data for OM and not for Prurisol is one of need for data to justify continuing with the OM trial. On that note, I have to believe that if Leo knew there was an issue with the Prurisol trial he'd simply stop it to conserve capital. But, I come from the perspective of trusting the CEO.







In Reply to 'cabel'
I sent this artilce to Leo,.... looks like we won't be getting P Interim Results.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5052936/

Interim analysis: A rational approach of decision making in clinical trial

He responded yesterday with this and based on his explanation I support him in his decision.

From Leo:
Please note the first paragraph of the article you sent me.

Quote from Abstract
Interim analysis of especially sizeable trials keeps the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project. Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, study design, and even an early declaration of success. Given the extraordinary size and complexity today, this rational approach helps to analyze and predict the outcomes of a clinical trial that incorporate what is learned during the course of a study or a clinical development program. Such approach can also fill the gap by directing the resources toward relevant and optimized clinical trials between unmet medical needs and interventions being tested currently rather than fulfilling only business and profit goals.

From Leo:
Our plan was to to do an interim analysis of patients who completed week 6 and look for a signal. Recruitment into the study was slower than anticipated. At this time, as most patients have completed the study, a look could create investigator bias. It will likely effect the Alpha and require more patients to be added to the study.

I do appreciate your suggestions but it is very complicated.

[sox040713]

My guess is that after Leo requested the interim analysis, the CRO cautioned him on possible investigator bias.

Leo has an idea of how the early patients are doing from the patient reports (placebo didn't show any activity at week 6 in Phase 2a). If they look good, the last thing Leo wants is to jeapodize the trial and more importantly, jeapodize any chance for a deal.

Leo has stated that his priority is partnership. His job isn't to please traders to flip on the interim result. Clinical trial is dynamic and changes can happen at any time.

[nerby]

Since this post seems to be the stick that got jammed into the Prurisol hornet's nest, just wondering if Leo has provided any further insights on the interim release, or if his complications have abated or increased? Thanks.