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Trubion Pharmaceuticals, Inc. Reports Positive Data from Phase 2b Re-treatment Study of TRU-015

SEATTLE, Oct. 19 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. today announced favorable safety and efficacy data following administration of a second course (R2) of re-treatment with 800 mg of TRU-015 for rheumatoid arthritis (RA). These data are the latest results from the ongoing open-label re-treatment portion of the Phase 2b (15002) RA study of TRU-015. Pfizer Inc. and Trubion are collaborating on the development of TRU-015 for the treatment of autoimmune and inflammatory diseases, including RA.

Data from the open-label re-treatment phase of the Phase 2b study demonstrate that repeat administration with TRU-015 is generally well-tolerated and results in sustained improvement in the signs and symptoms of RA. Results were presented at the 2009 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (AHRP) Annual Scientific Meeting in Philadelphia.

TRU-015 is Trubion's lead Small Modular Immunopharmaceutical (SMIP) product candidate directed against CD20+ B-cells.

The Phase 2b trial is a double-blind, placebo-controlled, randomized study that is designed to evaluate the safety, tolerability, pharmacodynamics (PD), pharmacokinetics (PK) and clinical activity of repeat doses of TRU-015. Of the 276 original patients who began the study, 240 (204 of whom were rheumatoid-factor positive, or RF+) entered the first open-label re-treatment portion (R1) of the trial. Trubion announced the first course of re-treatment data from this study at the 2009 EULAR Annual Meeting in June 2009.

A total of 226 patients from R1 were enrolled in the second re-treatment portion (R2) of the trial. At 24 weeks after the second re-treatment course, subjects in the group that had received 800 mg of TRU-015 in the initial treatment and re-treatments R1 and R2 achieved ACR 20, 50 and 70 response rates of 72%, 39% and 21%, respectively. Results were similar to the response rates achieved in R1 (70%, 40% and 23%, respectively).

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 and first re-treatment periods 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 (3.5%) enrolled in the trial experienced serious adverse events during the second re-treatment period. This is similar to observations made during the initial double-blind phase of the study (placebo 2%, 800 mg group 2%) and R1 (4%).

"We have now administered more than 1,300 doses of TRU-015 over four and a half years and continue to see positive and sustained results in RA patients. This reinforces our belief that TRU-015 could represent a differentiated treatment option when compared to other offerings on the market or in development," said Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "We believe a key to this differentiation should include data demonstrating both initial improvement in signs and symptoms and sustained improvement following multiple courses of re-treatment."

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, 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 Pfizer collaboration. Trubion's product pipeline also includes TRU-016, a novel CD37-targeted therapy for the treatment of B-cell malignancies developed under the company's Facet Biotech collaboration. In addition to Trubion's current clinical stage product pipeline, the Company is also developing its multi-specific SCORPION technology, both for targeting cell-surface molecules like CD79b and HLA-DR, as well simultaneously neutralizing soluble ligands like TNF and IL-6.

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 potential development and commercialization of TRU-015. 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 Pfizer collaboration, including the risk that the Company and Pfizer are unable to advance TRU-015 clinical development programs and regulatory applications and action at the expected rate, the risks that the Company is unable to develop or commercialize TRU-015, and such other risks as identified in the Company's quarterly report on Form 10-Q for the period ended June 30, 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 undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company's expectations.


  Jim DeNike
  Senior Director, Corporate Communications
  Trubion Pharmaceuticals, Inc.
  (206) 838-0500

  Waggener Edstrom Worldwide Healthcare
  Amy Petty
  Senior Account Executive
  (617) 576-5788

Posted: October 2009