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Trubion Pharmaceuticals Inc.
(Nasdaq: TRBN) announced positive data from a Phase 1/2a study
demonstrating that repeat administration with TRU-015 continues to produce
persistent responses and significant improvements in rheumatoid arthritis
(RA) signs and symptoms based on American College of Rheumatology (ACR)
criteria. Trubion also announced positive results following preliminary
analyses from a Phase 2b study in which patients have received one course
of re-treatment with 800 mg of TRU-015. TRU-015 is being developed by Wyeth
Pharmaceuticals in collaboration with Trubion.
TRU-015 Phase 1/2a Re-treatment Data: Re-treatment Administered Every
24 Weeks for 2 Years Produces Well-Tolerated and Consistent Results
Re-treatment data from the Phase 1/2a study (15001) were presented on
Oct. 26, 2008, in a poster session at the ACR 2008 Annual Meeting in San
Francisco. Patients treated with a single course of TRU-015 at 5 mg/kg or
higher in a previously conducted Phase 1/2a study (15001) were eligible for
re-treatment. Patients given an initial dose of 5 mg/kg received a single
infusion of 5 mg/kg upon re-treatment and those given higher doses of
TRU-015 received a single infusion of 15 mg/kg upon re-treatment. Patients
were eligible for repeat therapy at 24-week intervals.
Thirty-eight patients entered the Phase 1/2a re-treatment study; some
patients have received as many as seven courses of TRU-015 at the time of
this assessment. At 24 weeks, ACR 20, 50 and 70 response rates for 18
patients that have received their third re-treatment with 5 mg/kg or 15
mg/kg TRU-015 were 50%, 17% and 11%, respectively. Ongoing patient
evaluations demonstrated maintenance of ACR responses following
administration of a single dose of TRU-015 at six-month intervals along
with B-cell depletion and recovery following re-treatment, comparable to
results seen after initial treatment.
Results from the Phase 1/2a re-treatment study also indicated total
serum IgG levels were relatively preserved. In addition, subjects treated
with three or more courses of therapy experienced persistent decreases in
rheumatoid factor and IgM levels. 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. No neutralizing
antibodies to TRU-015 had been detected at the time of this assessment.
TRU-015 Phase 2b Re-treatment Data
A separate Phase 2b study (15002) is also ongoing. The initial
treatment results were presented last year. Re-treatment data from study
15002 were not available in time to present at ACR but will be submitted
for presentation in a future peer-reviewed forum. The objective of the two
ongoing re-treatment studies is to evaluate the safety; tolerability;
pharmacodynamics (PD), specifically, B-cell depletion over time;
pharmacokinetics; and immunogenicity of repeat doses of TRU-015 for RA
following initial administration.
Two hundred and forty patients entered the open-label re-treatment
portion of the Phase 2b study (15002) and received 800 mg of TRU-015. Data
was available for all 240 patients at the time of this evaluation, of which
204 patients were rheumatoid factor (RF) positive. Under the study
protocol, the efficacy endpoint was based on all randomized RF-positive
subjects who received any portion of study drug.
Based on the initial treatment results from studies 15001 and 15002,
the selected dose for re-treatment in 15002 and additional studies is 800
mg. Preliminary analyses demonstrate that at 24 weeks, ACR 20, 50 and 70
response rates for patients in the initial 800 mg dose group (n=43) who
were subsequently re-treated with 800 mg of TRU-015 were 70%, 40% and 23%,
respectively. Re-treatment with TRU-015 was generally well-tolerated. The
safety and PD effects after re-treatment were comparable to those seen
after initial therapy.
"We are very pleased with the results from the first course of
re-treatment under the Phase 2b study protocol," said Peter Thompson, M.D.,
FACP, president, CEO and chairman of Trubion. "These data demonstrate
improvement in RA signs and symptoms and, combined with data from more than
130 re-treatment courses administered over two years under the Phase 1/2a
study, continue to validate TRU-015 as a potential therapy for the
treatment of 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 SMIP therapeutics such as TRU-015 and SBI-087 for
autoimmune and inflammatory diseases, developed under the company’s
collaboration with Wyeth Pharmaceuticals. 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 clinical stage product pipeline, the company is also developing
additional product candidates that build on its product development
experience.
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, the risk that significant improvement in RA signs and symptoms
will not be observed after further re-treatment with TRU-015, 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 June 30, 2008, and from time to time in other reports filed by
Trubion with the U.S. Buy clomid pills Securities and Exchange Commission. These reports are
available on the Investors page of the company’s corporate website at
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.

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