Trubion Initiates Phase 1/2 Study of TRU-016 in CLL, Announces Next-Generation Product Candidate for RA and Provides Product Pip
March 27 2008 - 4:00PM
PR Newswire (US)
First Patient Dosed in Phase 1/2 Trial of TRU-016, Trubion's
Proprietary Product Candidate SEATTLE, March 27
/PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc.
(NASDAQ:TRBN) today announced that it has initiated a Phase 1/2
clinical trial of TRU-016, the company's lead proprietary Small
Modular ImmunoPharmaceutical (SMIP(TM)) drug candidate, for the
treatment of chronic lymphocytic leukemia (CLL). The company also
announced a new, next-generation product candidate for clinical
evaluation and provided an update on its product pipeline. TRU-016
for CLL and NHL Trubion today announced that patient dosing has
commenced in its Phase 1/2 clinical trial of TRU-016 for CLL. The
open label clinical trial is composed of two parts: a Phase 1 dose
escalation study designed to evaluate the safety, tolerability and
pharmacokinetics of TRU-016; and a Phase 2 expansion cohort
designed to further evaluate safety and to estimate clinical
activity of TRU- 016 in patients with previously treated CLL or
small lymphocytic leukemia. Trubion currently retains all
development and commercialization rights for the TRU-016 program.
This Phase 1/2 clinical trial is designed to enroll patients who
have undergone at least one prior therapy and have relapsed CLL or
small lymphocytic leukemia. Efficacy will be evaluated according to
disease response and progression status per the International
Response Criteria for CLL. Participants will receive intravenous
administration of TRU-016 over a four- week period. "This is an
important milestone for our proprietary program and we look forward
to the results of TRU-016's ongoing clinical evaluation," said
Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion.
"Our proprietary product candidate, TRU-016, has demonstrated
potent anti-tumor activity in pre-clinical evaluation and may
provide patients with improved therapeutic options or benefits when
used alone or in conjunction with chemotherapy or CD20-targeted
immunopharmaceuticals." SBI-087 for RA Trubion also announced today
that its collaboration partner Wyeth Pharmaceuticals, a division of
Wyeth (NYSE:WYE), has filed an investigational new drug (IND)
application for SBI-087 for rheumatoid arthritis (RA), and clinical
trial sites are preparing to enroll patients in a Phase 1 study. In
collaboration with Trubion, Wyeth Pharmaceuticals is developing
SBI-087 and other CD20-directed products. SBI-087 for RA builds on
Trubion and Wyeth's clinical experience with Trubion's lead
compound, TRU-015, and is based on Trubion's Small Modular
ImmunoPharmaceutical (SMIP(TM)) technology. With SBI-087, Trubion's
pipeline now includes two differentiated compounds under
development for the treatment of autoimmune and inflammatory
diseases. Trubion and Wyeth are leveraging Trubion's SMIP(TM)
technology to create a portfolio of product candidates with
customized mechanisms of action in an effort to optimize patient
safety, efficacy and convenience. The Phase 1 SBI-087 dose
escalation clinical trial is designed to evaluate the safety,
tolerability, pharmacokinetics and pharmacodynamics of a single
dose of SBI-087 in patients with RA. Pre-clinical research suggests
that SBI- 087, a fully humanized CD20-directed SMIP, has enhanced
potency in B-cell depletion in vivo compared to Rituxan and other
CD20-directed therapies. TRU-015 for RA In addition to SBI-087,
Trubion also announced today the protocol details and design of the
next Phase 2b study of TRU-015 for patients with RA that Trubion
believes could be supportive of a registration package. The
randomized, parallel, double-blind, placebo-controlled, dose
regimen-finding study will evaluate the safety and efficacy of two
dosing regimens 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 include the
American College of Rheumatology (ACR) 50 response measured at 24
weeks. Secondary outcome measurements will be ACR 20 and 70 and
DAS-28 responses. This study is currently preparing for participant
recruitment. "SBI-087 strengthens our product pipeline and
leverages the combined clinical experience of our strategic
collaboration with Wyeth," added Dr. Thompson. "We believe that
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 diseases." TRU-015 and SBI-087 for
SLE Wyeth intends to pursue clinical evaluation of SBI-087 in
Systemic Lupus Erythematosus (SLE) and an investigational new drug
filing is expected by the end of the year. As a result, Wyeth no
longer intends to evaluate TRU-015 in a planned Phase 1 study
originally designed to determine how the body absorbs and
chemically changes a single infusion of TRU-015 in subjects with
kidney disease caused by lupus. No patients were enrolled in the
planned TRU-015 Phase 1 study. TRU-015 for NHL Trubion also
announced today that Wyeth, in reviewing the competitive landscape
for CD20-directed therapies, has determined not to pursue such
therapies for oncology indications and, as a result, has
discontinued clinical development of TRU-015 for non-Hodgkin's
lymphoma. In addition to TRU-015 and SBI-087, additional projects
under the Wyeth collaboration continue to be pursued for
undisclosed indications. 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 lead product
candidate, TRU-015, has completed a Phase 2b clinical trial for the
treatment of rheumatoid arthritis and additional projects under the
Wyeth collaboration are being pursued for the treatment of Systemic
Lupus Erythematosus and other undisclosed indications. Trubion's
proprietary product candidate, TRU-016, is a novel CD37-targeted
therapy for the treatment of B-cell malignancies 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 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 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-K for the period ended
December 31, 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 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 For more information, contact: Trubion
Pharmaceuticals Inc. Jim DeNike Senior Director, Corporate
Communication (206) 838-0500 Waggener Edstrom Healthcare Jenny
Moede Senior Vice President (503) 443-7000 DATASOURCE: Trubion
Pharmaceuticals, Inc. CONTACT: Jim DeNike, Senior Director,
Corporate Communication, Trubion Pharmaceuticals Inc.,
+1-206-838-0500, , or Jenny Moede, Senior Vice President, Waggener
Edstrom Healthcare, +1-503-443-7000, Web site:
http://www.trubion.com/
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