Eight of the 10 patients had high-risk genomic features and no dose-limiting toxicities or serious adverse events had occurred. Mild (grade 1-2) infusion toxicity was observed in three patients. Beginning with the 0.3 mg/kg dose, all eight patients demonstrated evidence of biological activity including high-risk patients. Two patients had partial clearing of leukemia cutis, and the other six had 27% to 94% reduction in peripheral lymphocyte count. One patient had an increase in hemoglobin of 40% and a reduction in lymph nodes of 36%. Two patients had a significant increase in platelet count.
TRU-016 is a humanized SMIP protein therapeutic that targets the CD37 antigen and has shown potent anti-tumor activity in pre-clinical studies. Trubion initiated a Phase 1/2 clinical trial of TRU-016 in March 2008. The open-label clinical trial has two components: a Phase 1 dose escalation study designed to evaluate the safety, tolerability and pharmacokinetics of TRU-016, and a Phase 2 expansion cohort designed to further evaluate safety and estimate clinical activity of TRU-016 in patients with previously treated CLL or small lymphocytic lymphoma (SLL).
Abstract 8571 (May 30, 2009): Evaluation of the Effect of TRU-016 in Combination With Other Therapeutic Drugs in Models of Non-Hodgkin's Lymphoma
In addition, Trubion will also present at the 2009 ASCO Annual Meeting preclinical data evaluating TRU-016 interactions with the established therapeutics rituximab, doxorubicin, rapamycin, and bendamustine. Drugs were tested alone or in combination with TRU-016 for anti-proliferative effects on cell lines in vitro and on tumors in vivo.
Combination index analyses revealed that TRU-016 is synergistic with rituximab, bendamustine, or rapamycin and additive with doxorubicin in killing NHL cells in vitro. In vivo results show that treatment with the combination of TRU-016
|SOURCE Trubion Pharmaceuticals, Inc.|
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