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Trubion Announces Positive Data From a Phase 1 / 2 Study of TRU-016 for the Treatment of Chronic Lymphocytic Leukemia (CLL)
Date:6/1/2009

or as part of a combination regimen. Of the 24 patients with genetic data, 17 had high genomic risk factors, such as deletion of the 17p or 11q chromosomes. At the time of the presentation, patients had received intravenous doses of TRU-016 ranging from 0.03 mg/kg to 10 mg/kg over the course of four to 12 weeks.

Beginning with the 0.1 mg/kg dose, evidence of biologic activity was observed. The median reduction in peripheral lymphocytes was 67% and was as high as 98%. Two patients with leukemia cutis had complete or partial clearance of skin lesions. One patient had a 36% reduction in lymph node size, a 28% decrease in spleen size and a significant increase (44%) in hemoglobin. Mild grade 1 or 2 infusion toxicity was observed and there were three dose-limiting toxicities reported that all occurred in different dose cohorts. A maximum tolerated dose has not yet been reached.

Also presented at the ASCO Annual Meeting this week was data demonstrating that TRU-016 is additive or synergistic in combination with established therapeutics (Abstract 8571) and that TRU-016-mediated apoptosis in CLL cells occurs via a distinct mechanism of apoptosis compared with many other therapeutic agents utilized for the treatment of CLL (Abstract 3035). Copies of all three presentations are available on Trubion's website at http://investors.trubion.com/events.cfm.

"These results show promising single agent activity of TRU-016, even at surprisingly low doses, in a heavily pre-treated patient population most of whom harbored genetic lesions known to be associated with poor response to standard therapies," said Peter Thompson, M.D., FACP, president, CEO and chairman of Trubion. "These data suggest that this novel, first-in-class compound may become a new treatment option for patients with B-cell mali
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SOURCE Trubion Pharmaceuticals, Inc.
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