Seattle Genetics (ticker: SGEN, exchange: NASDAQ Global Market (.O))
News Release -
22-Jan-2004
Seattle Genetics Advances SGN-30 to Phase II Clinical Study BOTHELL, Wash.--(BUSINESS WIRE)--Jan. 22, 2004--Seattle Genetics,
Inc. (Nasdaq:SGEN) announced today that it has initiated a phase II
clinical trial of SGN-30, a monoclonal antibody for the treatment of
hematologic malignancies. The study is designed to evaluate the
antitumor activity and safety of SGN-30 in patients with Hodgkin's
disease or anaplastic large cell lymphoma.
"SGN-30 represents a targeted approach to cancer therapy and may
offer a much needed option for patients with advanced hematologic
malignancies, where currently available treatments are limited and can
cause toxic side effects," stated Clay B. Siegall, Ph.D., President
and Chief Executive Officer of Seattle Genetics. "Initiating the phase
II clinical trial is an important step toward our goal of developing
antibody-based therapeutics for patients with cancer."
The single-agent, open label study will accrue up to a total of 80
patients, 40 per disease indication. The trial, which is being
conducted at over 10 sites in the United States, is designed to assess
the tolerability and antitumor activity of SGN-30 in patients who have
relapsed or are refractory to prior therapies.
Seattle Genetics reported data from the phase I multi-dose
clinical trial of SGN-30 at the American Society of Hematology annual
meeting in December 2003. In the phase I study, 24 patients, in
six-patient cohorts, received weekly infusions of SGN-30 at doses
ranging from two to twelve milligrams per kilogram. SGN-30 was well
tolerated and antitumor activity was observed. One patient with
anaplastic large cell lymphoma demonstrated a complete response
lasting at least four months and six of the 24 patients had stable
disease.
SGN-30 is a genetically engineered monoclonal antibody that
targets CD30-positive hematologic malignancies, including Hodgkin's
disease and certain types of lymphomas and leukemias. In July 2003,
the company received orphan drug designation from the FDA for SGN-30
in Hodgkin's disease. Additionally, Seattle Genetics is conducting
preclinical studies to evaluate the potential of SGN-30 for the
treatment of immunologic diseases.
About Seattle Genetics
Seattle Genetics discovers and develops monoclonal antibody-based
therapeutics to treat cancer and other human diseases. The company has
built a diverse portfolio of product candidates targeted to many types
of cancer, including two being tested in multiple ongoing clinical
trials, SGN-30 and SGN-15, and three in preclinical development,
SGN-40, SGN-35 and SGN-17/19. The product candidates encompass three
platform technologies: genetically engineered monoclonal antibodies,
antibody-drug conjugates (ADCs) and antibody-directed enzyme prodrug
therapy (ADEPT). Seattle Genetics has developed leading ADC technology
comprised of highly potent drugs and stable linkers for attaching the
drugs to monoclonal antibodies. The company currently has license
agreements for its ADC technology with Genentech, Celltech Group and
Protein Design Labs and for its ADEPT technology with Genencor
International. More information about Seattle Genetics can be found at
www.seattlegenetics.com.
Certain of the statements made in this press release are
forward-looking, such as those, among others, relating to the
therapeutic potential of SGN-30. 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 risks related to adverse clinical results as our product
candidates move into and advance in clinical trials, risks inherent in
early stage development and failure by Seattle Genetics to secure or
maintain relationships with collaborators. 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, 425-527-4160
ppinkston@seagen.com
SOURCE: Seattle Genetics, Inc.
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