SEATTLE, Oct. 27 Trubion Pharmaceuticals Inc.(Nasdaq: TRBN) today announced positive data from a Phase 1/2a studydemonstrating that repeat administration with TRU-015 continues to producepersistent responses and significant improvements in rheumatoid arthritis (RA)signs and symptoms based on American College of Rheumatology (ACR) criteria.Trubion also announced positive results following preliminary analyses from aPhase 2b study in which patients have received one course of re-treatment with800 mg of TRU-015. TRU-015 is being developed by Wyeth Pharmaceuticals incollaboration with Trubion.
TRU-015 Phase 1/2a Re-treatment Data: Re-treatment Administered Every 24Weeks for 2 Years Produces Well-Tolerated and Consistent Results
Re-treatment data from the Phase 1/2a study (15001) were presented on Oct.26, 2008, in a poster session at the ACR 2008 Annual Meeting in San Francisco.Patients treated with a single course of TRU-015 at 5 mg/kg or higher in apreviously conducted Phase 1/2a study (15001) were eligible for re-treatment.Patients given an initial dose of 5 mg/kg received a single infusion of 5mg/kg upon re-treatment and those given higher doses of TRU-015 received asingle infusion of 15 mg/kg upon re-treatment. Patients were eligible forrepeat therapy at 24-week intervals.
Thirty-eight patients entered the Phase 1/2a re-treatment study; somepatients have received as many as seven courses of TRU-015 at the time of thisassessment. At 24 weeks, ACR 20, 50 and 70 response rates for 18 patients thathave received their third re-treatment with 5 mg/kg or 15 mg/kg TRU-015 were50%, 17% and 11%, respectively. Ongoing patient evaluations demonstratedmaintenance of ACR responses following administration of a single dose ofTRU-015 at six-month intervals along with B-cell depletion and recoveryfollowing re-treatment, comparable to results seen after initial treatment.
Results from the Phase 1/2a re-treatment study also indicated total serumIgG levels were relatively preserved. In addition, subjects treated with threeor more courses of therapy experienced persistent decreases in rheumatoidfactor and IgM levels. Re-treatment with TRU-015 did not result in an increasein any adverse events compared with the initial infusion, and the re-treatmentinfusions were well-tolerated. No neutralizing antibodies to TRU-015 had beendetected at the time of this assessment.
TRU-015 Phase 2b Re-treatment Data
A separate Phase 2b study (15002) is also ongoing. The initial treatmentresults were presented last year. Re-treatment data from study 15002 were notavailable in time to present at ACR but will be submitted for presentation ina future peer-reviewed forum. The objective of the two ongoing re-treatmentstudies is to evaluate the safety; tolerability; pharmacodynamics (PD),specifically, B-cell depletion over time; pharmacokinetics; and immunogenicityof repeat doses of TRU-015 for RA following initial administration.
Two hundred and forty patients entered the open-label re-treatment portionof the Phase 2b study (15002) and received 800 mg of TRU-015. Data wasavailable for all 240 patients at the time of this evaluation, of which 204patients were rheumatoid factor (RF) positive. Under the study protocol, theefficacy endpoint was based on all randomized RF-positive subjects whoreceived any portion of study drug.
Based on the initial treatment results from studies 15001 and 15002, theselected dose for re-treatment in 15002 and additional studies is 800 mg.Preliminary analyses demonstrate that at 24 weeks, ACR 20, 50 and 70 responserates for patients in the initial 800 mg dose group (n=43) who weresubsequently re-treated with 800 mg of TRU-015 were 70%, 40% and 23%,respectively. Re-treatment with TRU-015 was generally well-tolerated. Thesafety and PD effects after re-treatment were comparable to those seen afterinitial therapy.
"We are very pleased with the results from the first course ofre-treatment under the Phase 2b study protocol," said Peter Thompson, M.D.,FACP, president, CEO and chairman of Trubion. "These data demonstrateimprovement in RA signs and symptoms and, combined with data from more than130 re-treatment courses administered over two years under the Phase 1/2astudy, continue to validate TRU-015 as a potential therapy for the treatmentof RA."
Trubion is a biopharmaceutical company that is creating a pipeline ofnovel protein therapeutic product candidates to treat autoimmune andinflammatory diseases and cancer. The company's mission is to develop avariety of first-in-class and best-in-class product candidates, customized foroptimal safety, efficacy and convenience that it believes may offer improvedpatient experiences. Trubion's current product candidates are novelsingle-chain protein, or SMIP(TM), therapeutics, and are designed using itscustom drug assembly technology. Trubion's product pipeline includesCD20-directed SMIP therapeutics such as TRU-015 and SBI-087 for autoimmune andinflammatory diseases, developed under the company's collaboration with WyethPharmaceuticals. Trubion's product pipeline also includes Trubion'sproprietary product candidate, TRU-016, a novel CD37-targeted therapy for thetreatment of B-cell malignancies that is currently in Phase 1/2 clinicalevaluation. In addition to Trubion's current clinical stage product pipeline,the company is also developing additional product candidates that build on itsproduct development experience. More information is available in the investorssection of Trubion's website: http://www.trubion.com/investors.
Certain statements in this release may constitute "forward-lookingstatements" within the meaning of Section 21E of the Securities Exchange Actof 1934 and Section 27A of the Securities Act of 1933. These statementsinclude, but are not limited to, those related to the company's futureclinical development programs and the timing thereof, the company's futureregulatory filings and the timing and outcome thereof and the company'sexpected financial and operating results. These statements are based oncurrent expectations and assumptions regarding future events and businessperformance and involve certain risks and uncertainties that could causeactual results to differ materially. These risks include, but are not limitedto, the risk that significant improvement in RA signs and symptoms will not beobserved after further re-treatment with TRU-015, risks associated with thecompany's Wyeth collaboration, including Wyeth's control over developmenttimelines, the risks that the Company is unable to advance its clinicaldevelopment programs and regulatory applications and action at the rate itexpects, the risk that the Company does not achieve the financial andoperating results it expects, and such other risks as identified in thecompany's quarterly report on Form 10-Q for the period ended June 30, 2008,and from time to time in other reports filed by Trubion with the U.S.Securities and Exchange Commission. These reports are available on theInvestors page of the company's corporate website at http://www.trubion.com.Trubion undertakes no duty to update any forward-looking statement to conformthe statement to actual results or changes in the company's expectations.Contact: Jim DeNike Senior Director, Corporate Communications Trubion Pharmaceuticals Inc. (206) 838-0500 firstname.lastname@example.org http://www.trubion.com Waggener Edstrom Worldwide Healthcare Amy Petty Senior Account Executive (617) 576-5788 email@example.com TRBN-G
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