sox040713 Monday, 01/08/18 06:09:16 PM Re: To inf
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Posted On: 01/08/2018 6:21:15 PM
sox040713 Monday, 01/08/18 06:09:16 PM
Re: To infinity and beyond! post# 211800
Post #212005 of 212007
I have different expectation for Prurisol based on Phase 2a data plus increased dosages on easier patient population and assessment scale. Unlike you, I no longer focus on the mild population. Instead, I focus on the moderate population.
"Sub-population analyses further showed greater efficacy demonstrated in patients who had a baseline IGA score of 3 (“moderate”) as compared to those with a baseline score of 2 (“mild”). Some of these patients even experienced a 3-point reduction in their IGA score, going from “moderate” to “clear.” This suggests Prurisol may be more effective in treating moderate to severe psoriasis patients to a greater degree than those patients who exhibit less severe symptoms. In moderate to severe psoriasis studies, the placebo response also tends to be lower."
http://www.ipharminc.com/press-release/2016/1...y-endpoint
"Among patients participating in the study with the severest form of psoriasis, those having a baseline IGA score of 3 (“moderate”), the primary endpoint was met in 46.2% of patients who received Prurisol 200mg. This data was derived from analyses of all patients randomized across all 9 participating study sites."
"Additional preliminary data analyses of secondary endpoints show patients who received any dose of Prurisol, regardless of the treatment arm, had a 1-point improvement (using the IGA scoring system) at a higher rate than that of patients in the placebo arm. This is another clear indication of the drug’s efficacy."
http://www.ipharminc.com/press-release/2016/1...-psoriasis
As for Kevetrin, the current K-OC trial's secondary endpoint is tumor response so we'll have some idea of its efficacy at three times per week. If the efficacy data are impressive, IPIX can take advantage of FDA’s new initiative to approve a drug based on a biomarker. For K it could be p53/p21.
FDA approves first cancer treatment for any solid tumor with a specific genetic feature
“The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker) . This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated .
https://www.fda.gov/newsevents/newsroom/press...560167.htm
Re: To infinity and beyond! post# 211800
Post #212005 of 212007
I have different expectation for Prurisol based on Phase 2a data plus increased dosages on easier patient population and assessment scale. Unlike you, I no longer focus on the mild population. Instead, I focus on the moderate population.
"Sub-population analyses further showed greater efficacy demonstrated in patients who had a baseline IGA score of 3 (“moderate”) as compared to those with a baseline score of 2 (“mild”). Some of these patients even experienced a 3-point reduction in their IGA score, going from “moderate” to “clear.” This suggests Prurisol may be more effective in treating moderate to severe psoriasis patients to a greater degree than those patients who exhibit less severe symptoms. In moderate to severe psoriasis studies, the placebo response also tends to be lower."
http://www.ipharminc.com/press-release/2016/1...y-endpoint
"Among patients participating in the study with the severest form of psoriasis, those having a baseline IGA score of 3 (“moderate”), the primary endpoint was met in 46.2% of patients who received Prurisol 200mg. This data was derived from analyses of all patients randomized across all 9 participating study sites."
"Additional preliminary data analyses of secondary endpoints show patients who received any dose of Prurisol, regardless of the treatment arm, had a 1-point improvement (using the IGA scoring system) at a higher rate than that of patients in the placebo arm. This is another clear indication of the drug’s efficacy."
http://www.ipharminc.com/press-release/2016/1...-psoriasis
As for Kevetrin, the current K-OC trial's secondary endpoint is tumor response so we'll have some idea of its efficacy at three times per week. If the efficacy data are impressive, IPIX can take advantage of FDA’s new initiative to approve a drug based on a biomarker. For K it could be p53/p21.
FDA approves first cancer treatment for any solid tumor with a specific genetic feature
“The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker) . This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated .
https://www.fda.gov/newsevents/newsroom/press...560167.htm
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