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.
About Trubion
Trubion is a biopharmaceutical company that is creating a pipeline of novel protein therapeutic product candidates to treat autoimmune and inflammatory diseases and cancer. The Company's mission is to develop a variety of first-in-class and best-in-class product candidates, customized for optimal safety, efficacy and convenience that it believes may offer improved patient experiences. Trubion's current product candidates are novel single-chain protein, or SMIP(TM), therapeutics, and are designed using its custom drug assembly technology. Trubion's product pipeline includes CD20-directed SMIP therapeutics such as TRU-015 and SBI-087 for autoimmune and inflammatory diseases, developed under the company's Wyeth collaboration. Trubion's product pipeline also includes Trubion's proprietary product candidate, TRU-016, a novel CD37-targeted therapy for the treatment of B-cell malignancies that is currently in Phase 1/2 clinical evaluation. In addition to Trubion's current clinical stage product pipeline, the Company is also developing additional product candidates that build on its product development experience. More information is available in the investors section of Trubion's website: http://investors.trubion.com/index.cfm.
Forward-Looking Statements
Certain statements in this release may constitute "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934 and Section 27A of the Securities Act of 1933. These statements include, but are not limited to, those related to the Company's future clinical development programs and the timing thereof, the Company's future regulatory filings and the timing and outcome thereof. These statements are based on current expectations and assumptions regarding future events and business performance and involve certain risks and uncertainties that could cause actual results to differ materially. These risks include, but are not limited to, risks associated with the Company's Wyeth collaboration, including Wyeth's control over development timelines, the risks that the Company is unable to advance its clinical development programs and regulatory applications and action at the rate it expects, and such other risks as identified in the company's annual report on Form 10-Q for the period ended March 31, 2009, and from time to time in other reports filed by Trubion with the U.S. Securities and Exchange Commission. These reports are available on the Investors page of the Company's corporate website at http://www.trubion.com. Trubion undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company's expectations.
TRBN-015RA
Contact: Jim DeNike Senior Director, Corporate Communications Trubion Pharmaceuticals, Inc. (206) 838-0500 jdenike@trubion.com http://www.trubion.com
Waggener Edstrom Worldwide Healthcare Amy Petty Senior Account Executive (617) 576-5788 amyp@waggeneredstrom.com
