Replies to post #10988 on Innovation Pharmaceuticals Inc (IPIX)

[BioHedge]

So is it possible they are taking the blood samples and storing them until they get the cohort done and will then test the group? Or are they testing every sample when it comes in? If it is the latter then it be in mid/late December before we hear.

[govorchin]

thank you.

[TOB]

A drug's action is often both delayed and cumulative.

Clearly the blood work is before and after each dose. As you say, it would make no sense to do otherwise.

Changes in the biomarker p21 in peripheral blood lymphocytes [ Time Frame: baseline and 7 hours ] For biomarker analysis, p21 expression, assayed by qPCR, in peripheral blood lymphocytes after Kevetrin administration.

Any cumulative effect will show on the baseline, if there is p21 expression. Just like a Moving Average on CTIX charts.

The cumulative plasma concentrations will be mapped. Not just of bio-markers but of kevertrin itself. How quickly is kevertrin metabolized? How do the plasma levels relate to the clinical and cellular effect.

Anti-tumour effects measured by serum decreases in tumour markers is also a major secondary outcome. IMO there is over focus on just the p21.

A decrease in a tumor marker in the serum may also suggest evidence of anti-tumor efficacy. The following tumor markers will be evaluated: Carcinoembryonic antigen (CEA), Cancer Antigen 125 (CA125), Cancer Antigen 19-9 (CA19-9), Cancer Antigen 15-3 (CA15-3), Prostate Specific Antigen (PSA), or other appropriate markers. The choice of the individual tumor markers will be based on the type of tumor of the patient and the testing that has preceded the patient's participation in this study.

and change in tumour size is mega as a possible outcome.

Change in tumor size based on RECIST criteria version 1.1. using MRI, CT scan, and/or standard of care imaging (2, 4 & 6 months)

Lots of statistical analysis involved. Baseline, cumulative, and interval measurements.

Looking for a tolerable dose. Then comes Phase II to determine the outcomes when a tolerable dose is administered, is it also a clinically effective dose? The clinical outcomes may be minimal at the smaller initial doses during the toxicity study.

I see a major win if kevertrin just passes the Phase 1 and can reach a maximum tolerated dose that is believed to be in the clinically therapeutic range. Regardless of any clinical efficacy observed, which could be minimal, or below statistical significance at the low doses during the escalating study. It will be a huge bonus if that is reported, but not vital for Phase 1.

I reckon this will trigger the European study, a read of the toxicity, not clinical efficacy. IE. A safe therapeutic dose.

I don't see Phase 1 success in the initial weeks as a realistic goal at all, that sort of over-optimism leads to disappointment and not appreciating the more likely success. Just the continuation of the study after the initial doses is the good news for I'm focused on.

In other words, no news is also very good news!

Prurisol looks on track to a faster clinical result, likely the first buy-out target for Cellceutix IMO.

Just my layman's view of the study.

[noretreat]

I agree Doc. There is no other way to interpret this. 2 sample per person per dose level. 6 samples collected so far. THe hospital is in charge of the testing, so I don't expect a quick release of the data.