Trubion Announces Initiation Of Phase IIb Clinical Trial Of TRU-015 For The Treatment Of Rheumatoid Arthritis

Main Category: Arthritis / Rheumatology
Also Included In: Clinical Trials / Drug Trials
Article Date: 28 Sep 2006 - 0:00 PDT

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Trubion Pharmaceuticals, Inc., today announced it has initiated a Phase IIb clinical trial of TRU-015, the Company's lead Small Modular ImmunoPharmaceutical (SMIP(TM)) drug candidate for the treatment of rheumatoid arthritis (RA). The randomized, double-blind, placebo-controlled clinical trial is designed to evaluate clinical response rates in patients with rheumatoid arthritis. Upon initiation of this Phase IIb study and pursuant to the terms of its strategic collaboration with Wyeth (NYSE: WYE), Trubion will receive an aggregate of $8 million as a milestone payment and reimbursement of prior manufacturing-related costs.

"We believe our novel SMIP drug candidates represent an advancement in the treatment of RA," said Peter Thompson, M.D., co-founder, president and CEO of Trubion. "Our clinical trials so far have demonstrated that TRU-015 measurably improves the signs and symptoms of rheumatoid arthritis and we look forward to the results of our continuing clinical evaluation of TRU-015."

TRU-015 Phase IIb Clinical Trial Protocol

The Phase IIb randomized, double-blind, placebo-controlled clinical trial will enroll approximately 280 rheumatoid arthritis patients. These patients will be randomized into five groups to evaluate the safety and efficacy of an infused dose of TRU-015 compared to placebo for a 24-week period. Building on the findings of Trubion's Phase IIa clinical trial, this trial will evaluate the effect of a single infusion of TRU-015 ranging from 200mg to 1,600 mg per patient.

Similar to the Phase IIa study, this study will evaluate composite measurements of improvement in disease activity derived from parameters such as tender and swollen joint counts, patient and physician global assessments, patient assessment of pain and disability, and laboratory measures of inflammation as defined by the American College of Rheumatology.

About TRU-015 and SMIPs

Trubion and Wyeth are developing TRU-015, a SMIP drug candidate, as a potential new therapy for RA. SMIP(TM) drugs represent a novel class of immunotherapeutics that Trubion believes possess enhanced drug properties over monoclonal and recombinant antibodies.

In February 2006, the Company completed enrollment in a Phase IIa study in RA patients designed to demonstrate proof of concept that TRU-015 measurably improves the signs and symptoms of rheumatoid arthritis. In the first 24 weeks after receiving intravenous infusions of TRU-015, 72 percent of the subjects experienced a clinical response that is equal to or greater than that required to achieve an ACR20 response, 28 percent achieved an ACR50 response and 12 percent achieved an ACR70 response. In these measures of clinical response, ACR 50 and ACR70 indicate progressively greater responses from a baseline measure than ACR20, which is defined as an improvement of at least 20 percent from baseline in counts of both tender and swollen joints, as well as in at least three of five other disease activity parameters.

About Rheumatoid Arthritis

According to Datamonitor, RA is estimated to affect approximately 4.3 million people in the United States, Japan and Europe. In 2005, total reported worldwide sales of protein therapeutics used for the treatment of RA were $7.6 billion. Total worldwide sales of protein therapeutics for the treatment of RA are expected to grow to $10 billion in 2010.

About Trubion

Trubion is a biopharmaceutical company creating a pipeline of product candidates to treat autoimmune disease and cancer. The Company's product candidates are novel proteins known as single-chain polypeptides and are designed using its SMIP(TM) custom drug assembly technology. Trubion's business model is focused on large, established markets and is designed to reduce clinical development risks by developing product candidates directed against validated targets. In less than 24 months, the Company designed, developed and submitted to the FDA an Investigational New Drug application for its lead product candidate, TRU-015, which is currently being tested in a Phase IIb clinical trial for the treatment of rheumatoid arthritis. In December 2005, the Company entered into a collaboration agreement with Wyeth for the development and worldwide commercialization of certain therapeutics, including TRU-015. For additional information visit http://www.trubion.com.

Forward Looking Statements

This press release contains forward looking statements, including, without limitation, statements related to payments and reimbursements Trubion expects to receive; Trubion's future clinical development programs for TRU-015 and other SMIP drug candidates and the timing thereof; the therapeutic and commercial potential of TRU-015 and other SMIP drug candidates; future clinical development plans; the details of the clinical trials; and the anticipated future size of the RA market. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Trubion's current expectations. Forward-looking statements involve risks and uncertainties. Trubion's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the ability of the company to successfully conduct clinical trials for TRU-015 and other SMIP candidates; the uncertainty of the FDA approval process and other regulatory requirements; and the therapeutic and commercial value of Trubion's drug candidates. Trubion expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

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