SEATTLE, June 14 /PRNewswire-FirstCall/ -- Trubion
Pharmaceuticals, Inc. (Nasdaq: TRBN) today announced Pfizer's
decision to discontinue development of TRU-015 (PF-05212374), an
investigational drug in Phase 2 evaluation for the treatment of
rheumatoid arthritis (RA) developed under the companies' CD20
collaboration. However, Pfizer has confirmed that it will continue
to develop SBI-087 (PF-05230895), Trubion's next-generation,
humanized, subcutaneous CD20 RA product candidate also in Phase 2
clinical evaluation.
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Pfizer's decision is based on preliminary results from the Phase
2b (2203) randomized, parallel, double-blind, placebo-controlled
study designed to evaluate the efficacy and safety of two dosing
regimens (a single dose of 800mg TRU-015 compared with an induction
dose of 800mg TRU-015 followed by an additional dose of 800mg
TRU-015 at week 12) in combination with methotrexate in patients
with active rheumatoid arthritis.
Although the ACR (American College of Rheumatology) 20/50/70
results in the Phase 2 (2203) study were consistent with previous
studies and similar to other B-cell-depleting therapies, the
results did not meet the internally predefined primary endpoint, a
20% difference in ACR50 response compared with placebo at week 24
(p value = 0.06 for the single-dose group ACR 50 compared with
placebo and p= 0.12 for the induction-dose group ACR 50 compared
with placebo). A previously conducted interim analysis of the trial
data on approximately 50% of the total enrolled patient population
revealed that the primary endpoint had been met at that point in
time. No significant safety issues were reported, and they were not
a factor in Pfizer's decision to discontinue development.
TRU-015 demonstrated biologic activity including peripheral
B-cell depletion and a statistically significant decrease in
C-reactive protein in both dose groups compared with placebo.
Specifically, ACR 20 was 67.1% for the induction-dose group, 61.3%
for the single-dose group and 43.2% for the placebo group. ACR 50
was 27.4% for the induction dose, 29.3% for the single dose and
16.2% for placebo. ACR 70 was 9.6% for the induction dose, 9.3% for
the single dose and 2.7% for placebo. TRU-015 was generally
well-tolerated, and serious adverse events and medically important
infection rates in both dose groups were similar to placebo.
"Given the higher than usual placebo response, TRU-015 did not
meet the internal hurdle for continued development," said
Scott C. Stromatt, M.D., senior vice
president and chief medical officer at Trubion. "It is evident that
the drug has significant biological and clinical activity with no
significant safety concerns, but market dynamics dictate that we
pursue a differentiated and best-in-class product to bring into
Phase 3 development. At this time our next-generation CD20 SMIP
product candidate, SBI-087, meets that criteria, and its Phase 2
development will continue."
"Although we are not moving forward with this compound, we are
encouraged by our analysis to date of SBI-087," said Evan Loh, senior vice president of
BioTherapeutics Research and Development at Pfizer. "The goal of
our collaboration with Trubion continues to be the development of
best-in-class CD20 therapies, and we look forward to the results of
the ongoing SBI-087 Phase 2 study."
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, therapeutics, and are designed using
its custom drug assembly technology. Trubion's product pipeline
includes CD20-directed SMIP therapeutics such as SBI-087 for
autoimmune and inflammatory diseases, developed under the Company's
Pfizer collaboration. Trubion's product pipeline also includes
TRU-016, a novel CD37-targeted therapy for the treatment of B-cell
malignancies developed under the Company's Facet collaboration. In
addition to Trubion's current clinical stage product pipeline, the
Company is also developing its multi-specific SCORPION technology,
both for targeting cell-surface molecules as well as simultaneously
neutralizing soluble ligands. More information is available in the
investors section of Trubion's website:
http://investors.trubion.com/index.cfm.
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 future clinical development of the
Company's programs that are the subject of the Pfizer
collaboration, the timing and availability of data resulting from
these programs and Pfizer's intentions regarding these programs.
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 Pfizer collaboration, including
Pfizer's control over development timelines and over decisions
regarding the advancement of TRU-015 and SBI-087, the risks that
data resulting from our clinical development programs are
unfavorable or uncertain and such other risks as identified in the
Company's report on Form 10-Q for the quarter ended March 31, 2010, 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 website 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:
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Jim DeNike
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Senior Director,
Corporate Communications
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Trubion
Pharmaceuticals, Inc.
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(206)
838-0500
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jdenike@trubion.com
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http://www.trubion.com
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Waggener Edstrom
Worldwide Healthcare
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Amy Petty
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Account
Manager
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(617)
576-5788
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amyp@waggeneredstrom.com
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SOURCE Trubion Pharmaceuticals