SEATTLE, Jan. 11 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN) today announced that its collaboration partner, Pfizer, has initiated a Phase 2 clinical trial of SBI-087 (PF-05230895) for the treatment of rheumatoid arthritis (RA). SBI-087 is a next-generation, humanized Small Modular ImmunoPharmaceutical (SMIP(TM)) protein therapeutic directed against the CD20 antigen. SBI-087 is also being evaluated in Phase 1 clinical trials for RA and systemic lupus erythematosus (SLE).
The Phase 2 multi-center, randomized, placebo-controlled, double-blind, parallel-group, outpatient dose regimen-finding study will enroll approximately 200 patients who meet the criteria for RA with American College of Rheumatology (ACR) Functional class I, II or III, are seropositive, and who have been diagnosed with RA more than six months before trial initiation. Participants will be randomly assigned to receive either placebo or one of four SBI-087 dosing regimens. This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active RA, who are on a stable dose of methotrexate. The primary outcome measure will include responses based on the ACR criteria (ACR 20 response).
"Initiating the Phase 2 trial of SBI-087 for RA is an important milestone for Trubion," said Scott Stromatt, M.D., senior vice president and chief medical officer of Trubion. "We look forward to evaluation of our next-generation CD20 compound in a larger patient population and further definition of its role in helping Trubion to establish category leadership in autoimmune and inflammatory diseases."
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 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. More information is available in the investors section of Trubion's website: http://investors.trubion.com/index.cfm.
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 Pfizer collaboration, including Pfizer'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 quarterly report on Form 10-Q for the period ended Sept. 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 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.
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
SOURCE Trubion Pharmaceuticals, Inc.