Infinity Pharmaceutical (INFI)

 Infinity Pharmaceutical reports updated Phase 1 data showing encouraging clinical activity of IPI-145 in B-cell and T-cell lymphomas at ASCO Annual Meeting and announces initiation of Phase 2 clinical study in indolent non-Hodgkin lymphoma (INFI) 20.00 -6.95 : Co announced updated Phase 1 data from an ongoing study of IPI-145, its potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma in patients with relapsed/refractory lymphoma, a group of potentially fatal hematologic malignancies, or blood cancers. Data from the study showed that IPI-145 was well tolerated and clinically active in patients with B-cell or T-cell lymphomas, including indolent non-Hodgkin lymphoma (iNHL), T-cell lymphoma, mantle cell lymphoma (MCL) and Hodgkin lymphoma (HL). Data presented showed that IPI-145 was well tolerated, with a safety profile consistent with co-morbidities seen in patients with advanced hematologic malignancies. There have been no dose-related trends in adverse events at the doses evaluated, from 8 mg BID to 75 mg BID, in the total safety population or in patients with lymphoma. Among the 68 lymphoma patients enrolled in this study, the most frequent adverse event was elevation in transaminases (ALT/AST), which occurred in 21 patients (31 percent overall; 18 percent Grade 3 and one percent Grade 4). The majority of transaminase elevations were primarily managed by dose interruptions and dose reductions. Two (three percent of) patients discontinued treatment due to ALT/AST elevations. Fifty-three percent of lymphoma patients remain on study. Data also showed that IPI-145 is rapidly absorbed and demonstrates a linear pharmacokinetic (PK) profile through 75 mg BID, with complete inhibition of PI3K-delta and at least 50 percent inhibition of PI3K-gamma at doses = 25 mg BID.

Co also announced that its first Phase 2 study of IPI-145 in hematologic malignancies, which is enabled by data from the Phase 1 trial, is open for enrollment. This Phase 2, open-label, single-arm study is designed to evaluate the safety and efficacy of IPI-145 dosed at 25 mg twice daily (BID) in approximately 120 patients with refractory iNHL. In the Phase 1 study, among the 19 patients with iNHL evaluable for activity, 13 patients (68 percent) responded, with three complete responses and 10 partial responses. The majority of patients who responded were treated at doses = 25 mg BID.

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