FDAnews
www.fdanews.com/articles/102442-infinity-medimmune-advance-ipi-504

Infinity, MedImmune Advance IPI-504

December 19, 2007

Infinity Pharmaceuticals and MedImmune have begun the Phase II portion of a Phase I/II trial of IPI-504 in patients with advanced non-small cell lung cancer.

The open-label, multicenter trial will enroll 20 patients in two groups — one group with known epidermal growth factor receptor (EGFR) mutations and one group with wild-type EGFR.

If sufficient evidence of clinical benefit is observed in either cohort, 19 additional patients will be enrolled in that cohort.

IPI-504 will be administered by IV at 400 mg/m2 on a three-week cycle consisting of twice-weekly treatment for two weeks followed by one week off treatment, according to Infinity.