Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN) announced today the acceptance of two data presentations on its product candidate, TRU-016, at the 2009 American Society of Hematology (ASH) Annual Meeting Dec. 5-8, 2009 in New Orleans, Louisiana. The presentations will include additional positive data from 1) an ongoing Phase 1 clinical trial of TRU-016 for the treatment of chronic lymphocytic leukemia (CLL), and 2) a preclinical study demonstrating the effect of Trubion's Tru-ADhanCe(TM) technology in promoting enhanced natural killer cell mediated cytotoxicity against primary CLL cells. TRU-016 is Trubion's novel CD37-targeted therapy for the treatment of B-cell malignancies and is being developed in collaboration with Facet Biotech Corporation.
Presentation 3424: A Phase 1 Trial of TRU-016, An Anti-CD37 Small Modular Immunopharmaceutical (SMIP(TM)) Protein in Relapsed and Refractory CLL: Early Promising Clinical Activity
Monday, Dec. 7, 2009, 6:00 PM-8:00 PM Hall E (Ernest N. Morial Convention Center) Poster Board III-361
Conclusions: To date, TRU-016 is a well-tolerated treatment with minimal infusional toxicity and the maximum tolerated dose (MTD) has not been reached. One partial response (PR) and a median reduction of 83% in peripheral lymphocytosis have been observed. Encouraging reduction in lymph node/spleen size and improvement in normal hematopoietic function in patients with high-risk genomic CLL have been observed at low doses of CD37. The protocol has been amended to explore higher saturating doses of CD37. Future single-agent and combination studies of TRU-016 in CLL are warranted.