Dr. Menon has tested for reduction of CD4+ T cells in mice with 10 mg/kg of P.
"Prurisol was studied in mice that were irradiated then engrafted with human psoriatic tissue. Groups of ten mice were treated orally for 14 days with either 10 mg/kg KM-133 once/day, 10 mg/kg KM-133 twice/day, 7.5 mg/kg methotrexate once/day or acted as controls. The mice were followed for 180 days. Endpoints were skin appearance, histological observations, and blood levels of PRINS and IL-20. For these parameters, Prurisol treatment was compared to controls and methotrexate. CD4+ and CD8+ lymphocyte counts were also measured and compared to efalizumab. It significantly reduced all psoriatic endpoints measured relative to controls (p<0.01). The higher dose of Prurisol reduced psoriatic endpoints more than methotrexate (p<0.01). In addition, there was no recurrence of psoriasis in animals treated with Prurisol, whereas psoriasis recurred after an average of 61 days in animals treated with methotrexate. Immunosuppression in animals treated with Prurisol was less severe than in those treated with efalizumab. "
https://www.sec.gov/Archives/edgar/data/13552...ix_10k.htm
The dosage conversion from mouse to human is complicated, but Phase 2a provided IPIX the CD4+ T reduction levels in the 50, 100 and 200 mg arms. So they should be able to make an educated guess for the 300 and 400 mg arms. More on CD4+ T cells from the patent:
"The data shown in Figures 7 & 8 for CD4 and CD8, respectively, were obtained by Fluorescence-Activated Cell Sorting (FACS). The terms CD4 and CD8 denote the severity of inhibition of tolerance by the animals. A low CD4 and CD8 level indicates that the animals are getting immunocompromised, if the level goes down below 70% of the original levels then treatment should be stopped. CD4 and CD8 are members of the immunoglobulin superfamily. CD4 and CD8 (cluster of differentiation 4 or
are glycoproteins expressed on the surface of T helper cells, monocytes, macrophages, and dendritic cells."
https://www.google.com/patents/WO2013103601A1?cl=en
"Prurisol was studied in mice that were irradiated then engrafted with human psoriatic tissue. Groups of ten mice were treated orally for 14 days with either 10 mg/kg KM-133 once/day, 10 mg/kg KM-133 twice/day, 7.5 mg/kg methotrexate once/day or acted as controls. The mice were followed for 180 days. Endpoints were skin appearance, histological observations, and blood levels of PRINS and IL-20. For these parameters, Prurisol treatment was compared to controls and methotrexate. CD4+ and CD8+ lymphocyte counts were also measured and compared to efalizumab. It significantly reduced all psoriatic endpoints measured relative to controls (p<0.01). The higher dose of Prurisol reduced psoriatic endpoints more than methotrexate (p<0.01). In addition, there was no recurrence of psoriasis in animals treated with Prurisol, whereas psoriasis recurred after an average of 61 days in animals treated with methotrexate. Immunosuppression in animals treated with Prurisol was less severe than in those treated with efalizumab. "
https://www.sec.gov/Archives/edgar/data/13552...ix_10k.htm
The dosage conversion from mouse to human is complicated, but Phase 2a provided IPIX the CD4+ T reduction levels in the 50, 100 and 200 mg arms. So they should be able to make an educated guess for the 300 and 400 mg arms. More on CD4+ T cells from the patent:
"The data shown in Figures 7 & 8 for CD4 and CD8, respectively, were obtained by Fluorescence-Activated Cell Sorting (FACS). The terms CD4 and CD8 denote the severity of inhibition of tolerance by the animals. A low CD4 and CD8 level indicates that the animals are getting immunocompromised, if the level goes down below 70% of the original levels then treatment should be stopped. CD4 and CD8 are members of the immunoglobulin superfamily. CD4 and CD8 (cluster of differentiation 4 or
are glycoproteins expressed on the surface of T helper cells, monocytes, macrophages, and dendritic cells." https://www.google.com/patents/WO2013103601A1?cl=en
2
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