Replies to post #106298 on Innovation Pharmaceuticals Inc (IPIX)

[frrol]

That is correct, they wouldn't have included p21 assays in the Phase 1 formal design if they didn't believe the correlation meant something. And it does mean something, and it is tied to Kevetrin's success. And I explained what it meant and how it is tied.

I think your concern is that the Company is saying p21 increase = Kevetrin cures cancer, and yet they don't provide us the full data. I disagree that the Company is saying that. I also think that when they say Kevetrin shows activity against cancer, they are referring to the pre-clinicals' results.

I could be wrong.

[BonelessCat]

There would be a number of reasons for not releasing more data on p21. There are many pathways and cascades in p53 activation that results in cellular regulation, and regulation of senescence and apoptosis. The p21 presence is only part of the downstream affects of p53 repair, and the correlation between p53 and p21 is now much better understood than it was back in 2011 when the trial protocol was designed. As a secondary outcome p21 assay was given more emphasis as an indication of efficacy than it probably would be given today. As noted by Shapiro, there is data suggesting Kevetrin efficacy against some solid tumors independent of p21 increases and p53 up regulation.

Also, in the trial contract with Harvard medical and Dana Farber there is a clause regarding the control and dissemination of data and reports, as there always is for any contract between a CRO and trial site. Each party-Dana Farber/Harvard, the lead investigator, the sponsor CTIX-all agree to abide by the contract's outline for releasing information. I'm certain Leo must have permission from both Shapiro and Harvard before releasing any and all data. That permission can be very limiting when finally given and especially before the conclusion of a trial with the completion of bottom line data. For whatever reason, Shapiro didn't want Leo to elaborate beyond the information in the poster.

I've been an investor in the biopharma sector for more than 20 years. I have found the limited info during trials as frustrating as anyone. I'm also as disappointed as anyone that Leo didn't elaborate more and beyond the info in the poster, but for me this is not at all unexpected. While it's always great to get as much info from a biopharma as possible, my experience is that the investments to be most wary are those biopharmas who through CROs contract with less reputable clinical sites allowing the release of preliminary data from ongoing trials. Seems these early data releases are always to bolster stock price for rounds of financing and the preliminary data later becomes inaccurate when disappointing bottom line outcomes are finally made public.

Obviously, this won't be the case with CTIX, though there is still the (in my mind very remote) possibility that final data will be disappointing other than primary safety which is already well-established.