Monday, May 18, 2009 5:33:32 PM
On Monday May 18, 2009, 4:28 pm EDT
SEATTLE, May 18 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN - News) announced today that data from the re-treatment portion of a Phase 2b study (15002) of TRU-015 for rheumatoid arthritis will be presented on June 11 at the 2009 European League Against Rheumatism (EULAR) annual meeting in Copenhagen, Denmark. A copy of the abstract is now available at http://www.eular.org/.
Data from the first course of re-treatment demonstrate that TRU-015 for rheumatoid arthritis (RA) is well-tolerated and improves the signs and symptoms of RA as measured by American College of Rheumatology (ACR) response rates. The Phase 2b trial was designed to evaluate the safety, tolerability, pharmacodynamics (PD), pharmacokinetics (PK) and clinical activity of repeat doses of TRU-015. Trubion announced preliminary results from this study in Q4 2008.
TRU-015 is Trubion's lead Small Modular Immunopharmaceutical (SMIP(TM)) product candidate directed against CD20+ B-cells. Wyeth Pharmaceuticals and Trubion are collaborating on the development of TRU-015 for the treatment of autoimmune and inflammatory diseases, including RA.
In the initial portion of this double-blind, placebo-controlled, randomized Phase 2b clinical trial, 276 patients received a single intravenous infusion of either placebo, 200 mg, 400 mg, 800 mg or 1,600 mg of TRU-015. Of the 276 original patients who began the study, 240 (204 of whom were rheumatoid-factor positive, or RF+) entered the open-label re-treatment portion of the trial.
At 24 weeks after the first re-treatment, ACR 20, 50 and 70 response rates for subjects in the group (n=40) that had initially received an 800 mg dose and were re-treated with 800 mg of TRU-015 were 70%, 40% and 23%, respectively. ACR 20, 50 and 70 response rates in the group that had received an initial 1,600 mg dose and were subsequently re-treated with 800 mg were 68%, 30% and 14%, respectively. The safety and PD effects after re-treatment were comparable to those seen after initial therapy.
Numeric reductions in the Disease Activity Score 28 (DAS28), the Health Assessment Questionnaire (HAQ), and C-reactive protein (CRP) seen at the end of the double-blind treatment period were maintained or continued to improve during the open-label re-treatment period.
Infusions were generally well-tolerated and no patient experienced a serious adverse event on the day of infusion. Eight patients (3%) enrolled in the trial experienced serious adverse events during the first re-treatment period. This is similar to observations made during the initial double-blind phase of the study (placebo 2%, 800 mg group 4%).
"We are encouraged to see such strong results upon re-treatment of trial participants with TRU-015," said Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "TRU-015 is an important clinical candidate for Trubion and Wyeth. The positive data we've seen from the program to date demonstrate that TRU-015 may fill a distinct need for additional treatment options in the RA community. We look forward to the presentation of the full re-treatment data at the conference."
The full EULAR presentation will be available in the investor section of Trubion's website (http://investors.trubion.com/index.cfm) after the presentation on June 11, 2009.
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