Trubion Pharmaceuticals, Inc. Announces Initiation Of Phase 1 Study Of SBI-087 For The Treatment Of Systemic Lupus Erythematosus (SLE)

Main Category: Lupus
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 26 Mar 2009 - 4:00 PDT

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Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN) announced that its collaboration partner Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), has initiated a Phase 1 clinical trial of SBI-087, Trubion's next generation CD20 drug candidate, for the treatment of systemic lupus erythematosus (SLE). Based on Trubion's Small Modular ImmunoPharmaceutical (SMIP(TM)) technology, SBI-087 is also being evaluated in a Phase 1 clinical trial for rheumatoid arthritis (RA).

SBI-087 is a humanized SMIP drug candidate that is directed against the CD20 antigen. The Phase 1 SBI-087 dose escalation clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous or intravenous dose of SBI-087 in patients with SLE. The study will enroll patients who were diagnosed with SLE, based on the American College of Rheumatology Revised Criteria, more than six months prior to study initiation.

Preclinical data demonstrated that a single dose of SBI-087 resulted in more potent B-cell depletion in peripheral blood and lymphoid tissues than rituximab. The objective of the preclinical study conducted by Wyeth was to evaluate the pharmacokinetics and pharmacodynamics of SBI-087 following a single intravenous dose. Administration of SBI-087 resulted in dose-dependent B-lymphocyte depletion in peripheral blood and lymphoid tissues that was more profound and sustained in SBI-087-treated groups compared with rituximab.

"Initiation of the SBI-087 Phase 1 SLE clinical trial marks another important milestone in advancing our products developed in collaboration with Wyeth," said Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "We believe that SBI-087, along with our lead candidate TRU-015, have the potential to play an important role in improving patient care and helping us establish category leadership in autoimmune and inflammatory disease markets."

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-K for the period ended Dec. 31, 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 the Investors page of the company's corporate Web site 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.

Trubion Pharmaceuticals, Inc.
http://www.trubion.com