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SMALL BUSINESS
Seattle Genetics Initiates Phase I Clinical Trial of Antibody-Drug Conjugate SGN-75
Business Wire
Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that it has
initiated a phase I clinical trial of SGN-75 for metastatic renal cell
carcinoma and relapsed and refractory non-Hodgkin lymphoma. SGN-75 is an
antibody-drug conjugate (ADC) targeting CD70 that utilizes the company’s
proprietary technology.
“Our compelling preclinical data demonstrate that SGN-75 possesses
potent antitumor activity in models of both CD70-positive renal cell
carcinoma and hematologic malignancies,” said Clay B. Siegall, Ph.D.,
President and Chief Executive Officer of Seattle Genetics. “CD70 is
expressed on a variety of solid tumors, including renal cell carcinoma,
pancreatic, ovarian and lung cancers and glioblastoma as well as
multiple myeloma and several types of lymphoma. This broad expression
profile provides substantial and diverse therapeutic opportunities to
address unmet needs for patients with these malignancies.”
The single-agent phase I study is designed to enroll up to 80 patients
at multiple centers in the United States. The trial will evaluate the
safety, tolerability, pharmacokinetic profile and antitumor activity of
SGN-75 in order to identify a dose and schedule for future clinical
trials.
SGN-75 is an ADC comprising an anti-CD70 antibody attached to a potent,
synthetic drug payload, monomethyl auristatin F (MMAF), using Seattle
Genetics’ proprietary technology. The ADC is designed to be stable in
the bloodstream, but to release its payload upon internalization into
CD70-expressing tumor cells, resulting in targeted cell-killing.
About Non-Hodgkin Lymphoma
Non-Hodgkin lymphoma represents a diverse group of cancers that develop
in the lymphatic system and are characterized by uncontrolled growth and
accumulation of abnormal lymphocytes. Lymphocytes are white blood cells
that are responsible for defending the body against infection. The most
common forms of non-Hodgkin lymphoma are follicular and diffuse large
B-cell lymphoma. According to the American Cancer Society, approximately
66,000 cases of non-Hodgkin lymphoma are expected to be diagnosed in the
United States during 2009 and approximately 19,500 patients will die
from the disease.
About Renal Cell Carcinoma
Renal cell carcinoma (RCC) forms in the kidney, which filters and cleans
the blood. Metastatic RCC occurs when the cancer has spread to other
parts of the body. RCC is the most common type of kidney cancer in
adults, representing approximately 90 percent of cases. The American
Cancer Society estimates that there will be more than 57,700 new cases
of kidney cancer in the United States during 2009, and about 13,000
people will die from the disease.
About Seattle Genetics
Seattle Genetics is a clinical stage biotechnology company focused on
the development and commercialization of monoclonal antibody-based
therapies for the treatment of cancer and autoimmune disease. The
company’s lead product candidate, brentuximab vedotin (SGN-35), is in a
pivotal trial under a special protocol assessment with the FDA.
Brentuximab vedotin is empowered by Seattle Genetics’ proprietary ADC
technology comprising highly potent synthetic drugs and stable linkers
for attaching the drugs to monoclonal antibodies. In addition, Seattle
Genetics has four other product candidates in ongoing clinical trials:
lintuzumab (SGN-33), dacetuzumab (SGN-40), SGN-70 and SGN-75.
Dacetuzumab is being developed under a worldwide collaboration with
Genentech (a wholly-owned member of the Roche Group). Seattle Genetics
has collaborations for its ADC technology with a number of leading
biotechnology and pharmaceutical companies, including Genentech, Bayer,
CuraGen, a subsidiary of Celldex Therapeutics, Progenics, Daiichi
Sankyo, MedImmune, a subsidiary of AstraZeneca, and Millennium: The
Takeda Oncology Company, as well as an ADC co-development agreement with
Agensys, a subsidiary of Astellas Pharma. More information 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-75. 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 in this phase I clinical trial and
the risk of adverse clinical results as SGN-75 moves into and advances
in clinical trials. More information about the risks and uncertainties
faced by Seattle Genetics is contained in the company’s 10-Q for the
quarter ended September 30, 2009 filed 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.
Copyright Business Wire 2009
2009-11-16 09:00:00
COMMENTS ( 0 )
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