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An
entire of 37 affected individuals who had active RA on methotrexate were really
enrolled in 4 dose-escalating cohorts varying from 0.15 ug/kg to 1.50 ug/kg of
PRTX-100 or placebo, administered on a weekly basis for 4 weeks. Overall safety
and disorder activity were really tested over 16 weeks implementing the first
dose.
"The
primary disease activity achievements out of this trial demonstrated a suitable
safety profile and warrants further study of PRTX-100 at doses of 1.50 µg/kg
and better in a new clinical trial. As soon as the full analysis of the facts
from the South Africa survey is soon finished, we are going to be better
informed related to design regarding the new study which we desire will offer a
fuller understanding of overall safety and treatment result on RA disease
activity measures in addition to help define the optimum dose," stated
William E. Gannon, Jr., M.D., Chief Medical Officer of Protalex.
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