|[February 06, 2013]
Seattle Genetics Initiates Two Phase I Trials of SGN-CD19A
BOTHELL, Wash. --(Business Wire)--
Genetics, Inc. (Nasdaq: SGEN) today announced the initiation of two
phase I clinical trials of SGN (News - Alert)-CD19A, one for patients with B-cell acute
lymphoblastic leukemia (ALL) and one for patients with B-cell
non-Hodgkin lymphomas. SGN-CD19A utilizes Seattle Genetics'
industry-leading antibody-drug conjugate (ADC (News - Alert)) technology. The trials
are designed to assess the safety and antitumor activity of SGN-CD19A,
an ADC targeted to CD19.
"CD19 is expressed in a variety of hematologic malignancies, including
non-Hodgkin lymphoma and ALL, and has limited expression on normal
tissues making it an ideal ADC target. Our preclinical data indicate
that SGN-CD19A internalizes rapidly into tumor cells, resulting in
targeted cell killing," said Jonathan Drachman, M.D., Senior Vice
President, Research and Translational Medicine at Seattle Genetics. "Our
SGN-CD19A clinical development program comprises two trials that,
together, will provide a robust understanding of the activity and
tolerability of this ADC in patients with aggressive CD19-positive
lymphomas or ALL. In addition to the five ADCs already in ongoing
clinical trials, we plan to advance two additional ADC programs into the
clinic during 2013, underscoring our leadership in the field."
The studies are phase I, open-label, dose-escalation clinical trials.
The primary endpoints are to estimate the maximum tolerated dose and to
evaluate the safety of SGN-CD19A. In addition, the trials will evaluate
antitumor activity, pharmacokinetics, progression-free survival and
overall survival. One trial will enroll adult and pediatric patients
with relapsed or refractory B-cell ALL, as well as patients with Burkitt
lymphoma or leukemia or B-cell lymphoblastic lymphoma. The dose
escalation portion of the study is designed to evaluate both weekly and
every three week schedules and will enroll approximately 80 patients at
multiple centers in the United States. A second trial will enroll
patients with relapsed or refractory aggressive B-cell non-Hodgkin
lymphomas, including diffuse large B-cell lymphoma (DLBCL) and mantle
cell lyphoma. The dose escalation portion of the trial will evaluate
SGN-CD19A administered every three weeks and will enroll approximately
25 patients at multiple centers in the United States.
Both trials permit additional patients to be enrolled into expansion
cohorts following determination of the maximum tolerated dose.
For more information about the trials, including enrolling centers,
please visit www.clinicaltrials.gov.
SGN-CD19A is an ADC composed of an anti-CD19 antibody attached to a
synthetic cytotoxic cell-killing agent, monomethyl auristatin F (MMAF),
using Seattle Genetics' proprietary technology. The ADC is designed to
be stable in the bloodstream, and to release its cytotoxic agent upon
internalization into CD19-expressing cells. This approach is intended to
spare non-targeted cells and thus reduce many of the toxic effects of
traditional chemotherapy while enhancing the antitumor activity.
About Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia, also called acute lymphocytic leukemia or
ALL, is an aggressive type of cancer of the bone marrow and blood that
progresses rapidly without treatment. In ALL, lymphoblasts, which are
malignant, immature white blood cells, multiply and crowd out normal
cells in the bone marrow. ALL is the most common type of cancer in
children. According to the American Cancer Society, approximately 6,000
people were to be diagnosed with ALL during 2012 and more than 1,400
would die from the disease.
About Non-Hodgkin Lymphoma
Lymphoma is a general term for a group of cancers that originate in the
lymphatic system. There are two major categories of lymphoma: Hodgkin
lymphoma and non-Hodgkin lymphoma. Non-Hodgkin lymphoma is further
categorized into indolent (low-grade) or aggressive, including DLBCL.
DLBCL is the most common type of non-Hodgkin lymphoma. According to the
American Cancer Society, more than 70,000 cases of non-Hodgkin lymphoma
were to be diagnosed in the United States during 2012 and nearly 19,000
people would die from the disease.
About Seattle Genetics
Seattle Genetics is a biotechnology company focused on the development
and commercialization of monoclonal antibody-based therapies for the
treatment of cancer. The company's lead program, ADCETRIS, received
accelerated approval from the U.S. Food and Drug Administration in
August 2011 and approval with conditions from Health Canada in February
2013 for two indications. In addition, under a collaboration with
Millennium: The Takeda Oncology Company, ADCETRIS received conditional
approval from the European Commission in October 2012. Seattle Genetics
also has four other clinical-stage antibody-drug conjugate (ADC)
programs: SGN-75, ASG-5ME, ASG-22ME and SGN-CD19A. Seattle Genetics has
collaborations for its ADC technology with a number of leading
biotechnology and pharmaceutical companies, including Abbott, Agensys
(an affiliate of Astellas), Bayer, Celldex Therapeutics, Daiichi Sankyo,
Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as
ADC co-development agreements with Agensys and Genmab. 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-CD19A. 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 activity in these recently
initiated clinical trials and the risk of adverse events as SGN-CD19A
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, 2012 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.
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