Excellent post by Farrell.
farrell90 Saturday, 02/10/18 02:23:27 PM
Re: Scottwny post# 216842
Post #216883 of 216891
I can answer some of your questions.My comments are mine only and are probably incomplete and in part inaccurate. Others who read and post on the board are more qualified than I am. I hope they can respond and clarify any errors I make.
Frrol and TIAB are correct in that the company did not reveal all of their data or reasoning for their decisions, but no company is going to do that at this stage.
In the Kevetrin phase2 study the Western Blot test was done on the post Kevetrin treatment biopsy specimens. It showed Kevetrin activated the tumor's P53.
Why is that important? The Phase 1 Kevetrin study showed Kevetrin activated biomarkers in the blood showing P53 activation . A pharmaceutical company reviewing the data may say, OK that is good but how do we know the tumor cells are being activated? The activation could just be coming from the normal cells responding to Kevetrin. Before you go to any phase 2 or 3 study with combination drugs and radiation you need to prove to us Kevetrin is activating P53 in tumor cells.
The 2A study was important for that reason. Some posters were expecting efficacy such as tumor shrinkage or clinical response, but that was not a part of this study. The patients were not staged with PET scans, MRI's CT scans or ultrasounds either before or after the Kevetrin infusion. The study tumor biopsy results were the comparison of the pre and post treatment biopsies.The P53 finding was significant and important.
My feeling is the way the study was structured is the reason it was probably hard to recruit patients. Not only did the patients have to undergo invasive biopsies pre and post treatment,they were not going to be able to be told if there was any objective signs of improvement with subsequent testing. The other reason the study was stopped is it had just taken too much time and they had the data they needed to move forward...in their words to seek a partner.
IPIX made the first comments about oral Kevetrin in March of 2017.
At that time they had already done a substantial amount of preclinical studies for the oral drug. My bet is the oral drug will be ready for testing soon.
See my previous posts for links,216799,21678
Good luck,Farrell
farrell90 Saturday, 02/10/18 02:23:27 PM
Re: Scottwny post# 216842
Post #216883 of 216891
I can answer some of your questions.My comments are mine only and are probably incomplete and in part inaccurate. Others who read and post on the board are more qualified than I am. I hope they can respond and clarify any errors I make.
Frrol and TIAB are correct in that the company did not reveal all of their data or reasoning for their decisions, but no company is going to do that at this stage.
In the Kevetrin phase2 study the Western Blot test was done on the post Kevetrin treatment biopsy specimens. It showed Kevetrin activated the tumor's P53.
Why is that important? The Phase 1 Kevetrin study showed Kevetrin activated biomarkers in the blood showing P53 activation . A pharmaceutical company reviewing the data may say, OK that is good but how do we know the tumor cells are being activated? The activation could just be coming from the normal cells responding to Kevetrin. Before you go to any phase 2 or 3 study with combination drugs and radiation you need to prove to us Kevetrin is activating P53 in tumor cells.
The 2A study was important for that reason. Some posters were expecting efficacy such as tumor shrinkage or clinical response, but that was not a part of this study. The patients were not staged with PET scans, MRI's CT scans or ultrasounds either before or after the Kevetrin infusion. The study tumor biopsy results were the comparison of the pre and post treatment biopsies.The P53 finding was significant and important.
My feeling is the way the study was structured is the reason it was probably hard to recruit patients. Not only did the patients have to undergo invasive biopsies pre and post treatment,they were not going to be able to be told if there was any objective signs of improvement with subsequent testing. The other reason the study was stopped is it had just taken too much time and they had the data they needed to move forward...in their words to seek a partner.
IPIX made the first comments about oral Kevetrin in March of 2017.
At that time they had already done a substantial amount of preclinical studies for the oral drug. My bet is the oral drug will be ready for testing soon.
See my previous posts for links,216799,21678
Good luck,Farrell
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