Infinity/MedImmune's IPI-504 enters Ph I/II trial

Infinity Pharmaceuticals and fellow USA-based MedImmune have initiated the Phase II portion of a Phase I/II clinical trial of IPI-504, their lead heat-shock protein 90 inhibitor, in patients with advanced non-small cell lung cancer.

David Grayzel, vice president of clinical development and medical affairs at Infinity, said: "we are encouraged by the evidence of biological activity we saw in the Phase I portion of the study and are eager to further evaluate IPI-504 in Phase II." The goal of this open-label, multicenter clinical trial is to evaluate the anti-tumor activity of IPI-504. Initially, the Phase II portion of the study will enroll a total of 20 patients in two equal groups: one with known epidermal growth factor receptor mutations and another with wild-type EGFR. Evidence of anti-tumor activity will be evaluated using Response Evaluation Criteria in Solid Tumors.

If sufficient evidence of clinical benefit is observed in either cohort, 19 additional patients will be enrolled in that group. IPI-504 is being administered intravenously at 400mg/m2 on a three-week cycle, consisting of twice-weekly treatment for two weeks followed by one week off treatment.