Jul 26 2012
Protalex, Inc. (OTCBB: PRTX), a clinical stage biopharmaceutical company
that is developing a class of drugs designed to treat a wide array of
autoimmune and inflammatory diseases today announced preliminary
findings from its recently completed Phase 1b randomized, multiple-dose,
dose-escalation study. The study based in South Africa of PRTX-100 in
adult patients with active rheumatoid arthritis (RA) demonstrated that
PRTX-100 was generally safe and well tolerated in patients with active
RA at all dose levels.
A total of 37 patients who had active RA on methotrexate were enrolled
in 4 dose-escalating cohorts ranging from 0.15 ug/kg to 1.50 ug/kg of
PRTX-100 or placebo, administered weekly for 4 weeks. Safety and disease
activity were evaluated over 16 weeks following the first dose.
"The initial disease activity results from this trial demonstrated an
acceptable safety profile and warrants further study of PRTX-100 at
doses of 1.50 µg/kg and higher in a new clinical trial. Once the full
analysis of the data from the South Africa study is shortly completed,
we will be better informed of the design for the new study which we
expect will provide a fuller understanding of safety and treatment
effect on RA disease activity measurements as well as help define the
optimal dose," stated William E. Gannon, Jr., M.D., Chief Medical
Officer of Protalex.
Source: Protalex, Inc.
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