Seattle Genetics (ticker: SGEN, exchange: NASDAQ Global Market (.O))
News Release -
Seattle Genetics Initiates Phase II Clinical Trial of SGN-40 for the Treatment of Non-Hodgkin's Lymphoma
BOTHELL, Wash.--(BUSINESS WIRE)--Dec. 20, 2006--Seattle Genetics,
Inc. (Nasdaq: SGEN) announced today that the company has initiated a
phase II clinical trial of SGN-40 for the treatment of patients with
diffuse large B-cell lymphoma, the most common type of aggressive
non-Hodgkin's lymphoma (NHL).
Positive phase I data were reported last week at the American
Society of Hematology annual meeting demonstrating that SGN-40 is
well-tolerated and induces objective antitumor activity in patients
with relapsed or refractory NHL. Out of 31 evaluable patients, five
(16%) had measurable objective responses, including one complete
response ongoing after 41 weeks. Four patients achieved partial
responses, three of which remain durable at 10, 18 and 31 weeks. Three
of the five responses were in patients with diffuse large B-cell
lymphoma. Eight additional patients (26%) had stable disease at the
end of treatment. SGN-40 was well-tolerated using a dose-loading
schedule and no dose-limiting toxicity or immunogenicity was
"Advancing SGN-40 into mid-stage clinical trials is a significant
milestone for Seattle Genetics," said Clay B. Siegall, Ph.D.,
President and Chief Executive Officer of Seattle Genetics. "Relapsed
and refractory aggressive NHL represents an important market
opportunity for SGN-40 because currently available treatment options
inadequately address the needs of this patient population."
The single-agent phase II study is designed to assess the
antitumor activity, tolerability and pharmacokinetic profile of SGN-40
in patients with relapsed or refractory diffuse large B-cell lymphoma.
The trial is expected to enroll up to 40 patients at multiple centers
in the United States.
In addition to the diffuse large B-cell lymphoma study, SGN-40 is
in phase I clinical trials for relapsed/refractory multiple myeloma
and chronic lymphocytic leukemia. The company is also planning
combination studies in NHL and multiple myeloma to begin in 2007.
SGN-40 is a humanized monoclonal antibody that targets the CD40
antigen, which is highly expressed on most B lineage hematologic
malignancies including non-Hodgkin's lymphoma, multiple myeloma and
chronic lymphocytic leukemia. CD40 is also found on many types of
solid tumors, including bladder, renal and ovarian cancer, and may
also play a role in immunologic diseases.
About Diffuse Large B-Cell Lymphoma
Non-Hodgkin's lymphoma represents a diverse group of cancers that
develop in the lymphatic system. When lymphocytes, or white blood
cells, which are responsible for defending the body against infection,
divide and multiply uncontrollably, malignant tumors can form. The
American Cancer Society estimates that more than 58,000 people will be
diagnosed with NHL in the United States in 2006 and approximately
19,000 will die from the disease. Diffuse large B-cell lymphoma is an
aggressive subtype of NHL, representing approximately 70% of all newly
diagnosed cases of aggressive disease.
About Seattle Genetics
Seattle Genetics is a biotechnology company developing monoclonal
antibody-based therapies for the treatment of multiple types of
cancer, including non-Hodgkin's lymphoma, multiple myeloma, acute
myeloid leukemia and Hodgkin's disease. The company has also developed
proprietary antibody-drug conjugate (ADC) technology comprised of
highly potent synthetic drugs and stable linkers for attaching the
drugs to monoclonal antibodies. Seattle Genetics currently has license
agreements for its ADC technology with a number of leading
biotechnology and pharmaceutical companies, including Genentech,
Bayer, CuraGen and MedImmune. More information can be found at
Certain of the statements made in this press release are
forward-looking, such as those, among others, relating to the
therapeutic potential of SGN-40. Actual results or developments may
differ materially from those projected or implied in these
forward-looking statements. Factors that may cause such a difference
include the inability to show sufficient safety or activity in this
phase II clinical trial and the risk of adverse clinical results as
SGN-40 moves into and advances in clinical trials. More information
about the risks and uncertainties faced by Seattle Genetics is
contained in the Company's filings with the Securities and Exchange
Commission. Seattle Genetics disclaims any intention or obligation to
update or revise any forward-looking statements, whether as a result
of new information, future events or otherwise.
CONTACT: Seattle Genetics, Inc.
Peggy Pinkston, Corporate Communications, 425-527-4160
SOURCE: Seattle Genetics, Inc.