Seattle Genetics, Inc. SGEN today announced the initiation of two
phase I clinical trials of SGN-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) 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 lymphoma. 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.
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