Replies to post #221279 on Innovation Pharmaceuticals Inc (IPIX)

[DaubersUP]

Good post.

[JUST 10-11-12]

Fast tracked per website, should help get BTD?

[BonelessCat]

Can you provide where the company actually said this?

“K needs a pill. We had to abandon our 2A because the dosing was inadequate and cash is tight. We even had to lay people off and cut Menon's pay.”

Ironically, this quote is in the same post where you mention people going overboard. I’ll apologize if you post where the above was stated.

[farrell90]

IMO the Kevetrin 2A study was stopped for 3 primary reasons.

1 Kevetrin accomplished its primary purpose in the study; a better understand of its mechanism of action in tumor cells.

From the 2/10/2017 PR announcing the 2A study

"Cellceutix believes that this clinical trial, using IV dosing, will directly inform how Kevetrin modulates the p53 signaling pathway—one of the key questions asked by multiple pharmaceutical companies we are engaged with under Confidential Disclosure Agreements".

http://www.ipharminc.com/press-release/2017/2/10/cellceutix-announces-initiation-of-main-clinical-site-for-phase-2a-trial-of-p53-drug-candidate-kevetrin-in-the-treatment-of-platinum-resistantrefractory-ovarian-cancer

From the last Kevetrin 2A PR on/18/2018

" The Company initiated the trial for the purpose of demonstrating modulation of the key tumor-suppressor protein p53, which was achieved in analysis of the first patients at the lowest dose of Kevetrin..."

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

2. The company wants to focus its resources on developing the oral formulation of Kevetrin. From the same 2/10/2017 above PR above.

"Furthermore, as the Company has recently achieved 79 percent bioavailability of Kevetrin by oral administration in animal testing, Cellceutix anticipates being able to subsequently switch to oral dosing in future clinical trials, resulting in more frequent and convenient drug delivery. Bridging toxicology studies are now underway to enable this transition to oral dosing of patients."

3. The trial only enrolled 2 patients in almost a year and had no practical way of completing the 10 patient goal in a reasonable time. IMO they made a wise decision in stopping the trial and moving forward with the oral formulation of Kevetrin.

The following statement in the 2/8/2018 sums up IPIX's vision:

"The Company is adhering to a value-building strategy born from discussions with larger pharmaceutical companies interested in Kevetrin, one of the world’s most advanced p53 drug candidates. Securing the right development partner for Kevetrin remains an important objective."

Good luck, Farrell

[PlentyParanoid]

Right! IPIX better meet with FDA about B.

IPIX would benefit of getting at least SPA out FDA before starting p3. One thing a small biotech does not need is FDA saying after commercialization filing: "Sorry, we don't agree with your targets and methodology. You need to do this over."

I would try to get FDA committed for Kaplan-Meier style efficacy evaluation for incidence rate and onset combined plus mean count of days with SOM. That would put some needed intellectual rigor in SOM clinical trial business and probably would benefit B also. I bet they could get support for it from health insurance industry; they like to get their hands on better measures for cost estimation.

One can always dream.