Trubion Pharmaceuticals Inc.
(Nasdaq: TRBN) announced presentation of positive data from a Phase
IIb study that showed that Trubion's TRU-015 for rheumatoid arthritis (RA)
provided statistically significant efficacy after a single infusion of 800
mg or 1,600 mg. In addition, Trubion also announced presentation of data
showing that repeat administration with TRU-015 was well tolerated and
resulted in a consistent pharmacokinetic (PK) and pharmacodynamic (PD)
profile. Trubion is co-developing TRU-015 with Wyeth Pharmaceuticals, a
division of Wyeth (NYSE: WYE), for the treatment of rheumatoid arthritis.
"TRU-015's ability to significantly improve RA signs and symptoms
following a single infusion could represent a new level of convenience for
patients and physicians. These results also suggest that clinical responses
may be maintained during B-cell recovery," said Peter Thompson, M.D., FACP,
president, chief executive officer and chairman of Trubion. "We and our
partner have agreed on a design for our next study that we believe could be
supportive of a registration package, and we look forward to TRU-015's
continued evaluation."
TRU-015 Improves RA Disease Activity in Phase II Trial (ACR
Presentation L7)
On Sept. 10, 2007, Trubion announced preliminary analysis of results
for its TRU-015 Phase IIb randomized, double-blind, placebo-controlled,
multicenter clinical trial that included 276 patients with rheumatoid
arthritis. Patients were randomized equally into five groups that received
either placebo, 200 mg, 400 mg, 800 mg or 1,600 mg of TRU-015. The study
was designed to evaluate the safety and efficacy of a single intravenous
infusion of TRU-015 compared to placebo for a 24-week period.
Data announced previously showed the improvement in DAS-28 compared to
placebo was statistically significant in the 800 mg dose group at 12 weeks
and at all subsequent assessments, and in the 1,600 mg dose group at 16
weeks and at all subsequent assessments. At 24 weeks, ACR 20, 50 and 70
response rates in the 800 mg dose group were 65 percent, 26 percent and 0
percent, respectively. ACR 20, 50 and 70 response rates in the 1,600 mg
dose group were 61 percent, 13 percent and 4 percent, respectively. ACR 20,
50 and 70 response rates at 24 weeks in the placebo group were 33 percent,
9 percent and 2 percent, respectively.
At 24 weeks, significant improvement in the Health Assessment
Questionnaire Disability Index (HAQ DI) was observed in the TRU-015 1,600
mg group (-0.70 v -0.37 [p=0.008]) and the 800 mg group (-0.64 v-0.37
[p=0.035]). The HAQ DI measures patients' physical function in defined
activities. Median C-Reactive Protein (CRP) improvement was 57 percent in
the 1,600 mg group, 48 percent in the 800 mg group and 28 percent in the
placebo group. The CRP test measures the concentration of a protein that is
present during inflammatory episodes.
TRU-015 administered as a single dose was generally well tolerated, and
only one subject in the 400 mg group experienced a grade 3 adverse event on
the day of infusion.
Comparable Data Following Repeat Administration (ACR Presentation 309)
The objective of the re-treatment study was to evaluate the safety, PD,
PK 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.
Fifty-four patients were eligible for re-treatment, and at the time of
this analysis, re-treatment data were available for 36 patients. 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 with repeated single doses of TRU-015 at
six-month intervals through at least two retreatment courses. Total serum
IgG levels remained within normal limits. In addition, subjects treated
with three or more courses of therapy experienced persistent decreases in
rheumatoid factor and IgM levels without experiencing decreases in IgG or
IgA levels. No neutralizing antibodies to TRU-015 had been detected at the
time of this assessment.
Re-treatment with TRU-015 was generally well tolerated, and no grade 3
or 4 adverse events occurred on the day of infusion.
TRU-015 Clinical Development
Trubion and Wyeth have agreed on the design of the next clinical trial,
and both companies are working to finalize protocol details and plans for
study initiation. The randomized, double-blind, placebo-controlled,
multicenter trial will examine ways to further optimize efficacy while
evaluating dosing schedule. Additional study protocol details will be
provided after commencement of patient dosing.
About TRU-015 and SMIP(TM) Therapeutics
Trubion and Wyeth Pharmaceuticals are developing small modular
immunopharmaceutical (SMIP) therapeutics directed to CD20, an antigen
present on B cells. In addition to the ongoing development of TRU-015 for
RA, investigational new drug applications have been filed for TRU-015 for
systemic lupus erythematosus and non-Hodgkin's lymphoma. Trubion's SMIP
drug candidates represent a novel class of immunotherapeutics that the
company believes possess enhanced drug properties over monoclonal and
recombinant antibodies. SMIP product candidates are novel single-chain
polypeptide proteins designed using Trubion's custom drug assembly
technology. Trubion's current product candidates bind to specific antigen
targets on a cell's surface that have been clinically validated as
important in disease management either by existing products or by potential
products in clinical trials.
About Rheumatoid Arthritis
RA is a chronic disease, mainly characterized by inflammation of the
lining, or synovium, of the joints. It can lead to long-term joint damage,
resulting in chronic pain, loss of function and disability. According to
Datamonitor, RA is estimated to affect approximately 4.3 million people in
the United States, Japan and Europe. In 2006, total reported worldwide
sales of protein therapeutics used for the treatment of RA were greater
than $9.5 billion.
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 custom drug assembly technology. In December 2005,
the company entered into a collaboration agreement with Wyeth for the
development and worldwide commercialization of certain therapeutics,
including TRU-015. In addition, Trubion's TRU-016 program targets CD37, an
antigen present on B cells, for the treatment of chronic lymphocytic
leukemia and non-Hodgkin's lymphoma. The company filed an IND for TRU-016
in the fourth quarter of 2007. Trubion currently retains all development
and commercialization rights for the TRU-016 program. For additional
information visit trubion.
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,
the risk that the FDA may require modifications to our and Wyeth's design
of the next clinical trial for TRU-015, and the risks associated with
conducting additional clinical trials for TRU-015, the uncertainty of the
FDA approval process and the therapeutic and commercial value of Trubion's
drug candidates; and such other risks as identified in the company's
quarterly report on Form 10-Q for the period ended June 30, 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 trubion. 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.
trubion
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