S*BIO Pte Ltd announced that it has dosed the first 10 patients in a Phase 2 clinical trial of its novel JAK2 inhibitor SB1518 in the U.S. and Canada for the treatment of advanced lymphoid malignancies.
This multi-center, open-label, study is designed to primarily evaluate the efficacy and safety of SB1518 in patients with advanced lymphoid malignancies in five sites including M.D. Anderson, Rochester University, Cornell University, University of Nebraska, and British Columbia Cancer Center. Secondary objectives include duration of response and progression-free survival. Based on the safety and clinical benefit data from a Phase 1 trial, patients are receiving a 400mg dose of SB1518 orally daily. The trial will enroll up to 87 lymphoma patients and will determine the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies such as Hodgkin’s Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma.
Previously presented lymphoma data at the 52nd ASH Annual Meeting and Exposition demonstrated SB1518’s clinical benefits in a Phase 1 dose ranging study. Three patients showed partial response and 15 patients maintained stable disease states. The majority of the responses were sustained for greater than two months.
“The development of SB1518 in a second indication is a significant milestone in the clinical advancement of our lead JAK2 inhibitor,” said Dr. Jan-Anders Karlsson, CEO of S*BIO. “The initiation of this Phase 2 trial demonstrates our commitment in advancing this best-in-class compound and addressing the unmet medical need for an effective treatment of lymphoma. This trial closely follows our recent announcement of data from Phase 1/2 studies for SB1518 indicating its clinical efficacy and good tolerability for the treatment of patients with symptomatic myelofibrosis and enlarged spleens.”
S*BIO Pte Ltd and Onyx Pharmaceuticals, Inc. have a development collaboration and option and license commercialization agreement for the JAK2 inhibitors, SB1518 and SB1578, also known as ONX 0803 and ONX 0805, respectively. The development program includes indications for hematologic malignancies and myeloproliferative disorders. Onyx can elect to exercise its exclusive options for SB1518 (ONX 0803) and SB1578 (ONX 0805) separately and independently at certain predetermined stages of development for each compound in all indications in the United States, Canada and Europe. S*BIO retain rights to develop and commercialize SB1518 and SB1578 in the rest of the world.
Date: April 14, 2011
Source: S*BIO Pte Ltd