Trubion Pharmaceuticals Announces Presentation of Positive Data From Phase IIb and Re-treatment Studies With TRU-015 in Patients With Rheumatoid... (at Administration (ACR Presentation 309)...)

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Trubion Pharmaceuticals Announces Presentation of Positive Data From Phase IIb and Re-treatment Studies With TRU-015 in Patients With Rheumatoid Arthritis

Date:11/8/2007

at Administration (ACR Presentation 309)

The objective of the re-treatment study was to evaluate the safety, PD, PK and immunogenicity of TRU-015 for RA with repeated doses after receiving initial administration in a Phase I/IIa study. Patients treated with a single course of 5 mg/kg or higher in a previously conducted TRU-015 Phase I/IIa study were eligible for re-treatment. Patients who received a single infusion of 5 mg/kg received a single infusion of 5 mg/kg upon re-treatment, and those who received higher doses of TRU-015 received a single infusion of 15 mg/kg upon re-treatment. PD response of B-cells was also evaluated after initial treatment and after re-treatment.

Fifty-four patients were eligible for re-treatment, and at the time of this analysis, re-treatment data were available for 36 patients. B-cell depletion and recovery following re-treatment with TRU-015 was comparable to that seen after initial treatment. Ongoing patient evaluations showed maintenance of ACR responses with repeated single doses of TRU-015 at six-month intervals through at least two retreatment courses. Total serum IgG levels remained within normal limits. In addition, subjects treated with three or more courses of therapy experienced persistent decreases in rheumatoid factor and IgM levels without experiencing decreases in IgG or IgA levels. No neutralizing antibodies to TRU-015 had been detected at the time of this assessment.

Re-treatment with TRU-015 was generally well tolerated, and no grade 3 or 4 adverse events occurred on the day of infusion.

TRU-015 Clinical Development

Trubion and Wyeth have agreed on the design of the next clinical trial, and both companies are working to finalize protocol details and plans for study initiation. The randomized, double-blind, placebo-controlled, multicenter trial will examine ways to further optimize efficacy while evaluating dosing schedule. Additional study protocol details will be provided after commencemen
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