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
trubion.
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
trubion
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