Trubion Announces Initiation of Phase 2b Study of TRU-015 for the Treatment of Rheumatoid Arthritis
08 May 2008 - 6:00AM
PR Newswire (US)
Study to Evaluate Preferred Induction Dosing Regimen SEATTLE, May 7
/PRNewswire-FirstCall/ -- Trubion Pharmaceuticals Inc.
(NASDAQ:TRBN) today announced that its partner, Wyeth
Pharmaceuticals, a division of Wyeth (NYSE:WYE), has commenced
patient dosing in the next Phase 2b clinical trial of TRU-015 in
patients with rheumatoid arthritis (RA). In collaboration with
Trubion, Wyeth Pharmaceuticals is developing TRU-015, SBI-087 and
other CD20-directed products. The randomized, parallel,
double-blind, placebo-controlled, dose regimen-finding study will
evaluate the safety and efficacy of two dosing regimens
administered to approximately 216 patients with active,
seropositive RA on a background of methotrexate. The primary
outcome measurement for the TRU-015 Phase 2b study will be the
American College of Rheumatology (ACR) 50 response measured at 24
weeks. Secondary outcome measurements will be ACR 20 and 70 and
DAS-28 responses. "Data reported previously demonstrates TRU-015's
ability to significantly improve RA signs and symptoms, and
maintain response rates with repeat administration of single doses
given every six months," said Peter Thompson, M.D., FACP,
president, CEO and chairman of Trubion. "This study is designed to
help us identify an induction, or initial, dosing regimen and allow
us to further establish the most effective treatment regimen for
TRU-015. We believe this study has been designed in a way that
could support a registration package, and we look forward to the
results of this evaluation." With the addition of SBI-087 --
Trubion's next-generation, fully humanized CD20-directed SMIPTM --
Trubion's pipeline now includes two compounds under development for
the treatment of autoimmune and inflammatory diseases. Trubion and
Wyeth are leveraging Trubion's SMIPTM technology to create a
portfolio of product candidates with customized mechanisms of
action in an effort to optimize patient safety, efficacy and
convenience. 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
candidates 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
product candidates, the company is also developing additional
alliance and proprietary product candidates that build on its
product development experience. More information is available in
the investors section of Trubion's website: investors.trubion.com.
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 expected
financial and operating results, future clinical development plans,
the details of the clinical trials and the results and timing
thereof, and the timing of regulatory applications and action.
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 and the risk that the
current Phase 2b study of TRU-015 does not help the Company and
Wyeth identify a TRU-015 induction dosing regimen or further
establish the most effective treatment regimen for TRU-015, the
risks that the Company is unable to advance its clinical
development programs and regulatory applications and action at the
rate it expects, the risk that the Company does not achieve the
financial and operating results it expects and such other risks as
identified in the company's quarterly report on Form 10-K for the
period ended Dec. 31, 2007, 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. For more information, contact: Trubion
Pharmaceuticals Inc. Jim DeNike Senior Director, Corporate
Communication (206) 838-0500 Waggener Edstrom Worldwide Healthcare
Amy Petty Senior Account Executive (617) 576-5788 TRBN-G
DATASOURCE: Trubion Pharmaceuticals Inc. CONTACT: Jim DeNike,
Senior Director, Corporate Communication of Trubion Pharmaceuticals
Inc., +1-206-838-0500, ; or Amy Petty, Senior Account Executive of
Waggener Edstrom Worldwide Healthcare, +1-617-576-5788, , for
Trubion Pharmaceuticals Inc. Web site: http://www.trubion.com/
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