Seattle Genetics Initiates SGN-15 Phase II
2004-07-23 09:03 (New York)
Biomarker Clinical Trial
BOTHELL, Wash.--(BUSINESS WIRE)--July 23, 2004--Seattle Genetics, Inc.
(Nasdaq:SGEN) announced today that it has initiated a phase II clinical trial
of SGN-15, an antibody-drug conjugate (ADC), for the treatment of non-small
cell lung cancer (NSCLC). The phase II study will utilize a biomarker to assist
in evaluating the optimized dosing schedule of SGN-15 in combination with
Taxotere(R), a standard chemotherapy treatment for patients with lung cancer.
Completed clinical trials have demonstrated that the simultaneous
administration of SGN-15 and Taxotere may result in improved overall survival
compared to Taxotere alone. Preclinical studies have indicated that
administration of SGN-15 prior to Taxotere can significantly enhance the
therapeutic effect of the combination regimen compared to simultaneous
administration of the two drugs.
The open label phase II study will accrue approximately 30 evaluable patients
into two groups that will receive SGN-15 plus Taxotere either simultaneously or
separated by a three-day interval. Patients will be evaluated using a biomarker
that can be assessed using positron emission tomography (PET) imaging. This
diagnostic technology can be used to determine the relative activity of the two
dose schedules on an expedited basis prior to obtaining a difference in patient
survival.
"Our data indicate that the sequence and time interval of dosing SGN-15 and
Taxotere may play a significant role in the therapeutic benefit of this
combination," stated Clay B. Siegall, Ph.D., President and Chief Executive
Officer of Seattle Genetics. "By employing PET imaging, we will be able to
rapidly assess the impact that schedule has on the activity of this drug
combination to determine whether we may be able to improve upon the already
promising activity shown in our recently completed phase II study of SGN-15 in
NSCLC. Data from the biomarker study will be instrumental in the design of
potential pivotal clinical trials of SGN-15."
In June, Seattle Genetics reported data at the American Society of Clinical
Oncology (ASCO) 2004 Annual Meeting from its completed phase II clinical trial
of SGN-15 delivered simultaneously with Taxotere in patients with NSCLC. The
data indicate that the combination of SGN-15 and Taxotere was well tolerated
and may result in improved overall survival compared to Taxotere alone. Median
overall survival was 7.3 months for patients receiving SGN-15 in combination
with Taxotere compared to 5.9 months for patients receiving Taxotere alone.
Overall survival at one year and 18 months for patients receiving SGN-15 plus
Taxotere was 29 percent and 18 percent respectively compared to 24 percent and
8 percent respectively for patients receiving Taxotere alone.
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 three being tested in multiple ongoing clinical trials, SGN-30,
SGN-15 and SGN-40, and three in preclinical development, SGN-35, SGN-75 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 synthetic 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, Protein Design Labs and CuraGen and for its ADEPT technology
with Genencor International. More information about Seattle Genetics can be
found at www.seattlegenetics.com. |
