my response to TIAB... Just a couple questions fo
Post# of 72447
(Total Views: 284)
Posted On: 03/15/2018 4:33:38 PM
my response to TIAB...
Just a couple questions for you then.
The kevetrin trial was marked as a success by the company...
http://www.ipharminc.com/press-release/2018/2...3-observed
yet you say...
Why would there be mention of efficacy if it wasn't even part of the trial?
Primary Outcome Measures : 1.Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 Weeks ]
Reporting of Adverse Events, and severity of adverse events
2.Evaluate changes in biomarkers between pre-treatment sample and post-treatment sample [ Time Frame: 3 Weeks ]
Changes in RNA and/or protein level of pre-specified biomarkers associated with the p53 signalling pathway and apoptosis will be compared between pre-treatment sample (tumor biopsy, ascites fluid, and peripheral blood) and post-treatment sample (tumor biopsy, ascites fluid, and peripheral blood)
Secondary Outcome Measures : 1.Objective tumor response to treatment with Kevetrin [ Time Frame: 3 Weeks ]
Number of subjects in each response category (complete response, partial response, stable disease or progressive disease) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
2.Plasma concentrations of Kevetrin [ Time Frame: 5 Days ]
Measurement of Kevetrin systemic concentrations
https://clinicaltrials.gov/ct2/show/NCT030427...amp;rank=2
On to the next;
Did you miss the Kaplan-Meier Curves?
https://static1.squarespace.com/static/571535...erview.pdf
And prurisol...
Still double blinded by the way.
Study Background
Enrolling 115 patients, the placebo-controlled, randomized, double-blind trial tested the efficacy and safety of three separate, twice-daily, dosing regimens of Prurisol—50 milligram (mg) (50mg QD), 100mg (50mg BD), and 200mg (100mg BD). All patients were assessed via the 5-point Investigator’s Global Assessment (IGA) scale, ranging from a score of 0 (“clear”) to a score of 4 (“severe”). The IGA scale is preferred by the U.S. Food and Drug Administration (FDA) and is comparable to the older and more commonly used Psoriasis Area and Severity Index (PASI) in evaluating psoriasis severity of patients, with many dermatologists preferring it in the clinical trial setting. Generally, an IGA score of 0/1 demonstrates a strong association with a PASI 90 score.
http://www.ipharminc.com/press-release/2016/1...y-endpoint
PK Data Complements Efficacy Data
The PK data complements the efficacy data reported last week by showing a dose-dependent increase in exposure and maximum plasma concentration of the drug. Further, the elimination half-life was similar in each of the three dosing levels (50mg, 100mg, 200mg), with an average of 1.3 hours. The clearance of the drug was also similar across dosing levels, with an average of 80.1 liters per hour.
http://www.ipharminc.com/press-release/2016/1...-last-week
I'm not quite sure what you mean by small numbers other than patient participation. The current trial should be more than sufficient to move forward if it has decent results.
https://clinicaltrials.gov/ct2/show/NCT02949388
I'm not a scientist or a doctor so maybe I just don't get where you're coming from or your agenda.
Just a couple questions for you then.
The kevetrin trial was marked as a success by the company...
http://www.ipharminc.com/press-release/2018/2...3-observed
yet you say...
Quote:
In addition: I explained to the board that there would be no data about efficacy at the time of the first new K data, and even though many said I was wrong, I was right.
Why would there be mention of efficacy if it wasn't even part of the trial?
Primary Outcome Measures : 1.Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 Weeks ]
Reporting of Adverse Events, and severity of adverse events
2.Evaluate changes in biomarkers between pre-treatment sample and post-treatment sample [ Time Frame: 3 Weeks ]
Changes in RNA and/or protein level of pre-specified biomarkers associated with the p53 signalling pathway and apoptosis will be compared between pre-treatment sample (tumor biopsy, ascites fluid, and peripheral blood) and post-treatment sample (tumor biopsy, ascites fluid, and peripheral blood)
Secondary Outcome Measures : 1.Objective tumor response to treatment with Kevetrin [ Time Frame: 3 Weeks ]
Number of subjects in each response category (complete response, partial response, stable disease or progressive disease) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
2.Plasma concentrations of Kevetrin [ Time Frame: 5 Days ]
Measurement of Kevetrin systemic concentrations
https://clinicaltrials.gov/ct2/show/NCT030427...amp;rank=2
On to the next;
Quote:
I pointed out that there would be no data about B-OM area under the curve efficacy, and I was right about that also, despite attacks to the contrary
Did you miss the Kaplan-Meier Curves?
https://static1.squarespace.com/static/571535...erview.pdf
And prurisol...
Still double blinded by the way.
Quote:
the most important things I have written about for months are the P2b data and I am right about it, not wrong. I have been spot on to critique the bogus use of foolish percentages for small numbers.
Study Background
Enrolling 115 patients, the placebo-controlled, randomized, double-blind trial tested the efficacy and safety of three separate, twice-daily, dosing regimens of Prurisol—50 milligram (mg) (50mg QD), 100mg (50mg BD), and 200mg (100mg BD). All patients were assessed via the 5-point Investigator’s Global Assessment (IGA) scale, ranging from a score of 0 (“clear”) to a score of 4 (“severe”). The IGA scale is preferred by the U.S. Food and Drug Administration (FDA) and is comparable to the older and more commonly used Psoriasis Area and Severity Index (PASI) in evaluating psoriasis severity of patients, with many dermatologists preferring it in the clinical trial setting. Generally, an IGA score of 0/1 demonstrates a strong association with a PASI 90 score.
http://www.ipharminc.com/press-release/2016/1...y-endpoint
PK Data Complements Efficacy Data
The PK data complements the efficacy data reported last week by showing a dose-dependent increase in exposure and maximum plasma concentration of the drug. Further, the elimination half-life was similar in each of the three dosing levels (50mg, 100mg, 200mg), with an average of 1.3 hours. The clearance of the drug was also similar across dosing levels, with an average of 80.1 liters per hour.
http://www.ipharminc.com/press-release/2016/1...-last-week
I'm not quite sure what you mean by small numbers other than patient participation. The current trial should be more than sufficient to move forward if it has decent results.
https://clinicaltrials.gov/ct2/show/NCT02949388
I'm not a scientist or a doctor so maybe I just don't get where you're coming from or your agenda.
Quote:
Message in reply to:
consistently proven wrong? as if.
the most important things I have written about for months are the P2b data and I am right about it, not wrong. I have been spot on to critique the bogus use of foolish percentages for small numbers.
That has been my main focus as plenty of people have cited company graphs that hold little water.
Based on that I predicted that there would be no quick release of data unless it were very positive, and certainly there is no data out(blind or otherwise)
In addition: I explained to the board that there would be no data about efficacy at the time of the first new K data, and even though many said I was wrong, I was right. I pointed out that there would be no data about B-OM area under the curve efficacy, and I was right about that also, despite attacks to the contrary
There are small things I have been wrong about
Not the big things, though
We shall soon find out if my other main prediction- P2b more likely than not to fail- will come to pass
Always glad to acknowledge errors-
(7)
(0)