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Trubion Announces Preliminary Analysis of Phase IIb Results With TRU-015 in Rheumatoid Arthritis

Tuesday, September 11, 2007 General News
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SEATTLE, Sept. 10 Trubion Pharmaceuticals Inc.(Nasdaq: TRBN) today announced preliminary analysis of results from a PhaseIIb randomized, double-blind, placebo-controlled, multicenter clinical trialof its TRU-015 product candidate for rheumatoid arthritis (RA). The resultsindicated that Trubion's TRU-015 product candidate, at well-tolerated dosages,provided statistically significant improvements in RA signs and symptomscompared to placebo at 24 weeks. Trubion is co-developing TRU-015 with WyethPharmaceuticals, a division of Wyeth (NYSE: WYE), for the treatment ofrheumatoid arthritis.
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TRU-015 Phase IIb Clinical Trial Protocol and Results

The Phase IIb randomized, double-blind, placebo-controlled, multicenterclinical trial included 276 patients with rheumatoid arthritis who were alsoreceiving methotrexate as background therapy. Patients in the Phase IIb studywere randomized evenly into five groups that received either placebo, 200 mg,400 mg, 800 mg or 1600 mg of TRU-015.
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The study was designed to evaluate the safety and efficacy of a singleintravenous infusion of TRU-015 compared to placebo for a 24-week period, witha primary endpoint of improvement on the Disease Activity Score (DAS)-28 scaleat 12 weeks, and secondary endpoints including response rates at 24 weeksusing American College of Rheumatology (ACR) criteria.

Preliminary analysis indicates the improvement in DAS-28 compared toplacebo was statistically significant in the 800 mg dose group at 12 weeks andat all subsequent assessments, and in the 1600 mg dose group at 16 weeks andat all subsequent assessments. At 24 weeks, ACR 20, 50 and 70 response ratesin the 800 mg dose group were 65 percent, 26 percent and 0 percent,respectively. ACR 20, 50 and 70 response rates in the 1600 mg dose group were61 percent, 13 percent and 4 percent, respectively. ACR 20, 50 and 70 responserates at 24 weeks in the placebo group were 33 percent, 9 percent and2 percent, respectively.

TRU-015 administered as a single dose was generally well tolerated, andonly one subject in the 400 mg group experienced a grade 3 adverse event onthe day of infusion.

"We are pleased that the positive results of this study confirm theactivity seen in our prior study and demonstrate that TRU-015 can meaningfullyimprove disease activity in patients with RA," said Peter Thompson, M.D.,FACP, president, chief executive officer and chairman of Trubion."We are working with our partner to define the most effective developmentstrategy for TRU-015 in RA that minimizes time-to-market while maximizing ourcompetitive differentiation. We currently believe this will include additionalclinical study before commencement of a Phase III trial."

Conference Call Details

Trubion will host a conference call and webcast to discuss its preliminaryanalysis of the Phase IIb results with TRU-015 for RA. The call will be heldtoday at 1:30 p.m. Pacific Time, 4:30 p.m. Eastern Time. The live event willbe available from Trubion's Web site athttp://investors.trubion.com/events.cfm, or by calling (800) 289-0494 or(913) 981-5520. A replay of the discussion will be available beginning latertoday from Trubion's Web site or by calling (888) 203-1112 or (719) 457-0820,and entering 5763754. The telephone replay will be available through Sept. 14,2007.

About TRU-015 and SMIP(TM) Therapeutics

Trubion and Wyeth Pharmaceuticals are developing small modularimmunopharmaceutical (SMIP(TM)) therapeutics directed to CD20, an antigenpresent on B cells. In addition to the ongoing development of TRU-015 for RA,investigational new drug applications have been filed for TRU-015 for systemiclupus erythematosus and non-Hodgkin's lymphoma. Trubion's SMIP drug candidatesrepresent a novel class of immunotherapeutics that the company believespossess enhanced drug properties over monoclonal and recombinant antibodies.SMIP produc
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