Trubion Pharmaceuticals Announces Presentation of Positive TRU-015 and SBI-087 Data at the 2008 Annual European Congress of Rheu
17 June 2008 - 6:00AM
PR Newswire (US)
SEATTLE, June 16 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals
Inc. (NASDAQ:TRBN) today announced presentation of data at the 2008
Annual European Congress of Rheumatology meeting in Paris
demonstrating that repeat administration with TRU-015, Trubion's
lead candidate for the treatment of rheumatoid arthritis (RA),
continues to produce persistent responses on the American College
of Rheumatology (ACR) criteria and consistent pharmacodynamic (PD)
effects. In addition, preclinical data presented at the meeting
demonstrated that a single dose of SBI-087, a next-generation Small
Modular ImmunoPharmaceutical (SMIP(TM)) treatment for RA, resulted
in more potent B-cell depletion in peripheral blood and lymphoid
tissues than rituximab. Wyeth Pharmaceuticals is developing TRU-015
and SBI-087 in collaboration with Trubion. Repeated Therapy With
TRU-015 Is Well-Tolerated With Consistent PD Profile (OP-0252) The
objective of the ongoing re-treatment study was to evaluate the
safety, PD, pharmacokinetics and immunogenicity of TRU-015 for RA
with repeated doses after receiving initial administration in a
Phase I/IIa study. Patients treated with a single course of 5 mg/kg
or higher in a previously conducted TRU-015 Phase I/IIa study were
eligible for re-treatment. Patients who received a single infusion
of 5 mg/kg received a single infusion of 5 mg/kg upon re-treatment,
and those who received higher doses of TRU-015 received a single
infusion of 15 mg/kg upon re-treatment. PD response of B-cells was
also evaluated after initial treatment and after re-treatment.
Thirty-eight patients have entered the re-treatment study, and
re-treatment data were available for 36 patients with some patients
having received six courses of TRU-015 at the time of this
assessment. Re-treatment with TRU-015 did not result in an increase
in any adverse events compared with the initial infusion, and the
re-treatment infusions were well-tolerated. B-cell depletion and
recovery following re-treatment with TRU-015 was comparable to that
seen after initial treatment. Ongoing patient evaluations showed
maintenance of ACR responses following administration of a single
dose of TRU-015 at six-month intervals. Trubion announced in May
that Wyeth had commenced patient dosing in the next Phase 2b
clinical trial of TRU-015 in patients with RA. The randomized,
parallel, double-blind, placebo-controlled, dose-regimen-finding
study will evaluate the safety and efficacy of two dosing regimens.
Treatment will be 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 ACR 50 response measured at 24 weeks. Secondary outcome
measurements will be ACR 20 and Disease Activity Score-28
responses. SBI-087 Demonstrates Favorable in Vivo B-Cell Depletion
and Pharmacokinetic Profiles (THU0171) SBI-087 is a humanized SMIP
drug candidate that is directed against the CD20 antigen. 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. In April, Trubion
announced that Wyeth initiated a Phase 1 SBI-087 dose escalation
clinical trial that is designed to evaluate the safety,
tolerability, pharmacokinetics and pharmacodynamics of a single
dose of SBI-087 in patients with RA. This Phase I trial is designed
to enroll patients who meet the criteria for RA with Functional
Class I, II or III, and who have been diagnosed with RA more than
six months prior to the study with onset of RA after the age of 16.
"We believe SBI-087 and TRU-015 together will play an important
role in improving patient care and helping us establish category
leadership in autoimmune and inflammatory disease markets," said
Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion.
"With more than 100 re-treatment courses of TRU-015 now
administered, these data further demonstrate TRU-015's ability to
maintain consistent and predictable RA response rates following
re-treatment with a single dose given every six months. We look
forward to the results of Wyeth's ongoing TRU-015 Phase 2b study
designed to identify a preferred induction, or initial, dosing
regimen. The results from this study, combined with our
re-treatment experience to date, will allow us to further establish
TRU-015's competitive profile for patients with RA." 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 future regulatory filings and the timing and
outcome thereof and the company's expected financial and operating
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 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, 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-Q for the period ended March 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. TRBN-G Contact:
Jim DeNike Senior Director, Corporate Communications Trubion
Pharmaceuticals Inc. (206) 838-0500 Waggener Edstrom Worldwide
Healthcare Amy Petty Senior Account Executive (617) 576-5788
DATASOURCE: Trubion Pharmaceuticals Inc. CONTACT: Jim DeNike,
Senior Director, Corporate Communications 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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