We and our collaboration partner, Trubion Pharmaceuticals, are currently testing TRU-016 as a new therapy for chronic lymphocytic leukemia (CLL).

At the American Society of Hematology (ASH) meeting in December 2009, we presented positive early data from an ongoing study of TRU-016 in patients with relapsed and refractory CLL. Of the 33 patients enrolled, a majority --- 20 out of 33 patients --- had high-risk genomic features associated with a poor prognosis and had received multiple prior therapies. Evidence of TRU-016's biological activity was seen beginning with patients dosed at the 0.3 mg/kg dose level, including in high-risk patients. Partial responses (confirmed plus unconfirmed) were observed in five patients, including one patient with the 17p deletion cytogenetic abnormality. Two patients with leukemia cutis experienced clearing, one complete and one partial. At the 10 mg/kg dose, four of five patients with elevated peripheral lymphocyte counts experienced normalization. A total of 16 serious adverse events have been reported. The maximum tolerated dose has not yet been reached.

The phase 1 study of TRU-016 in patients with CLL continues to enroll patients. In parallel, we are exploring additional areas where a B-cell targeted therapy may have clinical utility, including non-Hodgkin’s lymphoma and autoimmune disease.

Please visit our TRU-016 publications page to view our most recent data presentations for this program.

For inquiries about our clinical trials, please call our information line at 650 454-1400 or visit the National Institutes of Health website (http://www.clinicaltrials.gov).