4:01PM Trubion Pharma and Facet Biotech announce presentation of positive TRU-016 data at the 2009 ASH Annual Meeting (TRBN) 3.71 -0.02 : The co and FACT announce the presentation of positive data from a phase 1 study of TRU-016 in patients with relapsed and refractory chronic lymphocytic leukemia (CLL). TRU-016 is a CD37-directed Small Modular ImmunoPharmaceutical (SMIP) protein therapeutic in development for the treatment of B-cell malignancies. "Unlike other peptide therapies that target CD20, TRU-016 targets CD37 and mediates both immune-mediated death and direct killing through a novel mechanism... The favorable toxicity profile and clinical activity with TRU-016 observed to date in this study suggests it has potential to be a major contributor to combination strategies that are impacting CLL treatment outcome." Data were presented today for 33 patients enrolled in the phase 1 TRU-016 dose escalation trial (abstract 3424). A majority of patients (20/33) had high-risk genomic features associated with a poor prognosis and had received multiple prior therapies. Evidence of TRU-016 biological activity was seen beginning with patients dosed at the 0.3 mg/kg dose level, including in high-risk patients. Partial response (PR) was observed in five patients, including one patient with the 17p deletion cytogenetic abnormality. Partial response was determined following investigator assessment and the two-month confirmation of these responses is pending. 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 were reduced to normal levels. A total of 16 serious adverse events have been reported. The maximum tolerated dose (MTD) has not yet been reached
surf's up......crikey
