Agreed 100%. Here's my reply to SS last night (bef
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Posted On: 02/08/2018 3:45:29 PM
Agreed 100%. Here's my reply to SS last night (before the PR).
sox040713 Thursday, 02/08/18 02:51:38 AM
Re: scottsmith post# 216205
Post #216347 of 216522
K-OC didn't fail. A failed trial means the primary outcome isn't met or the FDA stops the trial early due to safety concerns. The primary outcomes of K-OC are safety and MOA. The FDA didn't stop the trial early so safety wasn't a concern in the first cohort. As for MOA, the preliminary analysis clearly stated,
"Modulation of the p53 protein was observed in response to administration of Kevetrin. Pathways analyses also point to concomitant cell cycle modulation at the level of gene expression. Importantly, these data are the first to directly support, in ovarian cancer patient tumors, Kevetrin’s ability to affect p53 and associated molecular pathways—a central gene signaling network involved in regulating cell growth and the cell cycle, helping to prevent cancer."
http://www.ipharminc.com/press-release/2017/1...ncer-trial
IPIX has said repeatedly that due to K's short half-life, dosing orally several times per day is the ideal treatment. So it's not a big surprise when Leo said "The Company believes that further pathways detail and clinical tumor responses would best be observable with more frequent and potentially higher drug exposure."
I think IPIX is satisfied with the MOA findings and they want to save money and time so they can focus on the oral formulation. From an ethical standpoint, if you think the current regimen won't produce any meaningful tumor response, it's better to save the time and troubles of the trial so the ovarian cancer patients can participate in another trial.
The oral regimens will determine whether K succeeds or fails. From the same PR,
"Running in parallel, the Company is making plans to develop Kevetrin as an oral agent (tablet or capsule) that could be dosed multiple times per day, leveraging its short half-life and pharmacokinetic profile. Bioavailability and other lab studies have been encouraging."
sox040713 Thursday, 02/08/18 02:51:38 AM
Re: scottsmith post# 216205
Post #216347 of 216522
K-OC didn't fail. A failed trial means the primary outcome isn't met or the FDA stops the trial early due to safety concerns. The primary outcomes of K-OC are safety and MOA. The FDA didn't stop the trial early so safety wasn't a concern in the first cohort. As for MOA, the preliminary analysis clearly stated,
"Modulation of the p53 protein was observed in response to administration of Kevetrin. Pathways analyses also point to concomitant cell cycle modulation at the level of gene expression. Importantly, these data are the first to directly support, in ovarian cancer patient tumors, Kevetrin’s ability to affect p53 and associated molecular pathways—a central gene signaling network involved in regulating cell growth and the cell cycle, helping to prevent cancer."
http://www.ipharminc.com/press-release/2017/1...ncer-trial
IPIX has said repeatedly that due to K's short half-life, dosing orally several times per day is the ideal treatment. So it's not a big surprise when Leo said "The Company believes that further pathways detail and clinical tumor responses would best be observable with more frequent and potentially higher drug exposure."
I think IPIX is satisfied with the MOA findings and they want to save money and time so they can focus on the oral formulation. From an ethical standpoint, if you think the current regimen won't produce any meaningful tumor response, it's better to save the time and troubles of the trial so the ovarian cancer patients can participate in another trial.
The oral regimens will determine whether K succeeds or fails. From the same PR,
"Running in parallel, the Company is making plans to develop Kevetrin as an oral agent (tablet or capsule) that could be dosed multiple times per day, leveraging its short half-life and pharmacokinetic profile. Bioavailability and other lab studies have been encouraging."
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