Innovation Pharmaceuticals Inc (IPIX)

[MinnieM]

Clinical trial probability of success for those interested. Following is from: https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf



Upcoming ph3 trials have a high probability of success based on the data supplied in above link. $IPIX has one approved to start, a ph3 (Brilacidin ABSSSI)

Brilacidin for Oral Mucositis will likely be approved to start a ph3 since it reduces the incidence of OM.



Upcoming data on Prurisol will tell us the probability of it going on to a ph3. Based on the ph2a, there is a good chance of the ph2b doing well enough to move to a ph3. We find out soon.

As it stands, Brilacidin is the best bet for a partner/sale since it is furthest along and can get into a couple of ph3's quickly.

Kevetrin has been the slow one to move and has an interesting history. I think they were forced to start out at low dosages for several reasons. First of all, the poor safety history of previous p53 drugs had to give the FDA pause when looking at approving this trial. The patients were stage 4 cancer patients and needed to be treated with care. Approval was needed before progressing from one cohort to the next.

Then, you had competing oncology trials at Dana Farber. It was surprisingly slow in recruiting. As a matter of fact, this experience of competing trials is likely the reason that the company decided against running the Brilacidin ph2 Oral Mucositis trial at MD Anderson. They’d already been burnt with slow recruitment at a location with competing trials. The relationship between Dr Fried and Dr Menon is likely the primary reason Kevetrin ended up at Dana Farber.

The recently completed/closed Kevetrin ph2a Ovarian Cancer trial was able to get the data sought in the primary outcome measures with only 2 patients.

https://clinicaltrials.gov/ct2/show/NCT03042702?term=cellceutix&rank=2

For a better understanding of the company thinking behind this small trial one might want to read the following quote from the interview with Dr Bertolino. https://seekingalpha.com/article/3988240-interview-new-cellceutix-president-dr-bertolino

Q: Kevetrin TM has an Orphan Drug designation from the FDA for ovarian cancer. Can you tell me what your plan is for getting a mid-stage trial going for this indication?

"A: Kevetrin TM for ovarian cancer is a very high priority for us. Everything that I have seen on Kevetrin TM and its effect on p53 has me hopeful that we could have a blockbuster in hand. What we're doing right at this moment is making some modifications to the Phase 2 trial design in a manner that I believe will shorten the duration of the study. Our short-term goal of the planned ovarian cancer trial is aimed at unequivocally demonstrating modulation of p53 directly in tumor tissue, as well as associated clinical response measured by RECIST. Further, we believe that it will be an anchor if we can demonstrate that the response in rodents is mirrored in treatment of patients.

To accomplish this, we are doing studies in the lab in animal models of ovarian cancer aimed at demonstrating the effect of Kevetrin TM activation of p53 to treat the disease. This strategy should enable us to further anchor the effect of Kevetrin TM in the Phase 2 trial as it relates to key biologic measures. In my opinion, many companies make a mistake by prematurely jumping to a long-term endpoint such as progression-free survival, before proof of concept is firmly established. It is a compelling story to tell if you can see the effect of a compound in an animal model replicated in human studies. Kevetrin TM with a confirmed novel mechanism of action should get potential partners very excited. Our goal is to do a very rewarding deal with a major partner and for that to happen, we need to give them superb data.

I'll add that we are also actively working on different formulations of Kevetrin TM, including an oral formulation and different delivery methods. The Cellceutix team was already working on this area and I am completely on-board with filling a void in oncology to give patients better options for receiving their therapy. It goes without saying that a new, effective drug with a better delivery method has significant potential."

See following link for company pr discussing the Kevetrin ph2a OC trial results.
http://www.ipharminc.com/press-release/2018/2/8/innovation-pharmaceuticals-concludes-successful-phase-2a-trial-of-kevetrin-for-ovarian-cancer-intra-tumor-modulation-of-p53-observed

Brilacidin is the drug that gives me comfort to keep holding since it is furthest along.

Just a quick fyi, SA has changed it's rules and has blocked free access to articles after 10 days. One must be a subscriber to read all content. However, they have made a new exception which allows authors to pick five articles to remain available for free. This exception should go into effect within about 2 weeks. I've picked the above as one of my five. So, if you can't read it now, try again in a week or two. Anyone that has commented on an article will always be able to access the comment stream in all articles. Funny new rules, but, I have no control over that.