TRBN Trubion Pharmaceuticals (MM)

SEATTLE, May 12 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN) today announced the acceptance of two Phase 1 data presentations on SBI-087 (PF-05230895) at the 2010 annual congress of the European League Against Rheumatism (EULAR) in Rome, Italy. Presentations will include promising data from a Phase 1 study of SBI-087 for the treatment of rheumatoid arthritis (RA) and a Phase 1 study of SBI-087 for the treatment of systemic lupus erythematosus (SLE). Copies of both abstracts are available at http://www.eular.org. SBI-087 is Trubion's next-generation CD20-directed small modular immunopharmaceutical (SMIP™) product candidate and is being developed in collaboration with Pfizer.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090320/TRUBIONLOGO)

The Phase 1 trial was designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ascending single doses of SBI-087 in patients with controlled RA. At the time of the abstract submission, 60 patients enrolled in the open-label Phase 1 trial had received intravenous doses of SBI-087 ranging from 0.15 to 2 mg/kg or subcutaneous doses of 50, 100, 200 and 300 mg. All of the patients studied had well-controlled RA.

Data demonstrate that SBI-087, given as a single subcutaneous dose with a day-of-treatment oral steroid regimen, is generally well-tolerated and induces potent B-cell depletion. The most frequently reported adverse events were upper respiratory infection, headache, diarrhea, chills, fever, fatigue and bruising at the injection site. SBI-087 administered at subcutaneous doses of at least 100 mg depleted peripheral blood B-cell levels to less than 5 cells/uL for at least 12 weeks. Trubion's collaboration partner, Pfizer, initiated a Phase 2 study of SBI-087 for RA in January to evaluate safety and efficacy of SBI-087. The 200 mg subcutaneous dose was selected to be further investigated as part of this trial.

At the time of abstract submission, data was available for 18 patients enrolled in an open-label Phase 1 study of SBI-087 for SLE. Patients received intravenous doses of 0.5 mg/kg or subcutaneous doses of 25 mg or 75 mg of SBI-087. All patients had well-controlled SLE.

Preliminary data demonstrate that SBI-087 was generally well-tolerated by patients with well-controlled lupus when administered as a single subcutaneous dose with a day-of-treatment oral steroid regimen. Adverse events included chills, extreme fatigue, upper respiratory tract infection and muscle spasms. Subcutaneous doses of 75 mg of SBI-087 depleted peripheral blood B-cell levels in all subjects to below 20 cells/uL. Five of six subjects in this cohort had B-cell levels below 5 cells/uL by week two. By week 10, B-cell levels increased to above 20 cells/uL in four of six subjects. The Phase 1 trial is ongoing and is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ascending single doses of SBI-087 in patients with controlled SLE.

"Data to be presented at EULAR reinforce the need for differentiated treatments for RA and SLE," said Scott Stromatt, M.D., chief medical officer of Trubion. "We look forward to continued evaluation of our second generation CD20 compound and further defining its role in the treatment of RA and SLE."

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 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 as well as simultaneously neutralizing soluble ligands. 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, the timing and availability of data resulting from these programs and the intentions of the Company's collaboration partners, including Facet and its parent corporation, Abbott, the Company's future regulatory filings and the timing and outcome thereof, the Company's receipt of future milestone payments under existing collaborations, the Company's projected cash requirements for future periods and other projected financial results. 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 and over decisions regarding the advancement of some of the Company's clinical development programs, risks associated with the Company's Facet collaboration, including Facet's and Abbott's control over development timelines and over decisions regarding the advancement of some of the Company's clinical development programs, the risks that the Company is unable to advance its clinical development programs and regulatory applications and action at the rate it expects, the risks that data resulting from our clinical development programs are unfavorable or uncertain, the risk that we do not achieve the milestones we expect to generate milestone payments under our collaboration agreements or otherwise do not receive these milestone payments for any reason, the risk that our projected cash requirements exceed our expectations and such other risks as identified in the Company's report on Form 10-Q for the quarter ended March 31, 2010, 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-087RA

SOURCE Trubion Pharmaceuticals, Inc.