Seattle Genetics Reports on SGN-30 and SGN-40 Clinical Programs
2004-12-06 09:01 (New York)
at the American Society of Hematology Annual Meeting
BOTHELL, Wash.--(BUSINESS WIRE)--Dec. 6, 2004
Seattle Genetics, Inc. (Nasdaq:SGEN) reported data from
its SGN-30 and SGN-40 clinical programs at the American Society of
Hematology (ASH) 2004 Annual Meeting in San Diego. Data from ongoing
phase II studies of SGN-30 in anaplastic large cell lymphoma (ALCL)
and Hodgkin's disease demonstrate that it is well tolerated and has
antitumor activity. Dose escalation is continuing in a phase I trial
of SGN-40 in multiple myeloma, with preliminary data indicating that
the product candidate is well tolerated at low doses. Preclinical
studies of SGN-30 and SGN-40 suggest synergies with conventional
chemotherapy regimens.
"We are pleased with the continued progress of our SGN-30 and
SGN-40 programs as demonstrated by the data we are presenting as ASH,"
stated Clay B. Siegall, Ph.D., President and Chief Executive Officer
of Seattle Genetics. "We continue to enroll patients in multiple
clinical trials of both product candidates and to expand into other
indications, including our recent initiation of SGN-40 in
non-Hodgkin's lymphoma. We expect to report additional data from both
programs in 2005."
SGN-30 Phase II ALCL Clinical Trial
SGN-30 is a monoclonal antibody that targets CD30, which is highly
expressed on T-cell lineage hematologic malignancies. Seattle Genetics
reported preliminary data from an ongoing phase II clinical trial
designed to evaluate SGN-30's antitumor activity, safety and
pharmacokinetic profile in patients with relapsed or refractory
systemic ALCL.
ALCL patients receive six milligrams per kilogram (mg/kg) of
SGN-30 for six consecutive weeks followed by a four-week observation
period. To date, eight patients with a median age of 59 years and a
median of 2.5 prior therapies have been enrolled in the study.
Multiple doses of SGN-30 have been well tolerated. Of the six
evaluable patients, two exhibited objective responses, including one
complete response and one partial response. One patient had stable
disease and three patients had progressive disease. Drug-related
adverse events have been typically mild and consistent with antibody
administration.
SGN-30 Phase II Hodgkin's Disease Clinical Trial
SGN-30 is also being evaluated as therapy for patients with
Hodgkin's disease. In this study, a total of 22 patients have been
enrolled to date. Fifteen patients received SGN-30 at a dose of six
mg/kg and seven patients received a dose of 12 mg/kg, in each case on
a weekly basis for six consecutive weeks. Patients are evaluated for a
four-week period following treatment. The median age of enrolled
patients is 34 years and median number of prior therapies is three.
Seventy-three percent of the patients enrolled in the study had
received prior bone marrow transplant. Of the 16 evaluable patients,
six patients had stable disease with an average duration of 4.8
months. Ten patients experienced disease progression. The most common
drug-related adverse event has been fatigue. Newly enrolled Hodgkin's
disease patients will be administered a dose of 12 mg/kg.
SGN-40 Phase I Multiple Myeloma Clinical Trial
SGN-40 is a humanized monoclonal antibody that targets the CD40
antigen, which is expressed on most B-cell lineage hematologic
malignancies, including multiple myeloma, non-Hodgkin's lymphoma and
chronic lymphocytic leukemia. Seattle Genetics is conducting an
open-label, multi-dose, single-arm phase I study designed to evaluate
the safety, antitumor activity and pharmacokinetic profile of
escalating doses of SGN-40 in patients with relapsed or refractory
multiple myeloma.
To date, a total of ten patients in cohorts of at least three have
been treated with SGN-40 at dose levels of 0.5, 1.0 or 2.0 mg/kg on a
weekly basis for four weeks. Patients are followed for up to six weeks
after their last dose. All patients had progressive disease upon
enrollment and were heavily pretreated with a median of five prior
therapies and median age of 58 years. Two of the 10 patients had
stable M-protein levels over the four-week treatment period. No grade
3 or 4 non-hematologic dose limiting toxicities have been observed.
Seattle Genetics is continuing to dose escalate in this phase I
study of SGN-40 in multiple myeloma and plans to report additional
data during 2005. In addition, the company recently expanded its
SGN-40 clinical program by initiating a phase I study in non-Hodgkin's
lymphoma.
SGN-30 Preclinical Studies
Preclinical studies of SGN-30 in combination with conventional
chemotherapeutics commonly used in CD30-positive malignancies, such as
bleomycin, demonstrate a synergistic response that significantly
enhances antitumor activity compared to either agent administered
alone. The data suggest that a clinical regimen combining SGN-30 and
chemotherapy may result in increased efficacy. Based on these
preclinical findings, Seattle Genetics plans to initiate a clinical
trial of SGN-30 in combination with chemotherapy in patients with
Hodgkin's disease in 2005.
SGN-40 Preclinical Studies
SGN-40 was evaluated in preclinical studies in combination with
several immunomodulatory drugs (IMiDs) used in the treatment of
multiple myeloma. Results indicate that the combination induced
enhanced cell-killing activity compared with either single agent,
suggesting that a clinical regimen combining SGN-40 and IMiDs may
result in increased efficacy.
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,
CuraGen and Bayer and for its ADEPT technology with Genencor
International. More information about Seattle Genetics can be found at
www.seattlegenetics.com. |
