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07.12.2013 17:17:44

Infinity Pharma Updates Phase 1 Data Of IPI-145 In Indolent Non-Hodgkin Lymphoma

(RTTNews) - Infinity Pharmaceuticals Inc. (INFI) announced updated Phase 1 data from an ongoing study of IPI-145, its oral inhibitor of phosphoinositide-3-kinase or PI3K-delta and PI3K-gamma, in patients with relapsed/refractory indolent non-Hodgkin lymphoma (iNHL), a potentially fatal hematologic malignancy (blood cancer). Data from the study showed that IPI-145 was clinically active, with an overall response rate of 73 percent, including three complete responses, among patients receiving IPI-145 dosed at = 25 mg twice daily or BID.

Data also showed that 53 percent of patients remained progression free for over one year. These data support DYNAMO, the ongoing Phase 2 study of IPI-145 in patients with refractory iNHL.

The company said the findings were presented today at the 55th Annual Meeting of the American Society of Hematology (ASH).

Additionally, Infinity presented translational data showing that IPI-145 affects key signaling molecules in the tumor microenvironment, providing a potential mechanistic rationale underlying the clinical activity of IPI-145 observed in both iNHL and chronic lymphocytic leukemia or CLL.

Updated Phase 1 data in 15 patients with relapsed/refractory iNHL who received IPI-145 at doses = 25 mg BID were included in a poster presentation.

Data showed that IPI-145 was clinically active, with a 73 percent overall response rate (11 of 15 evaluable patients) and a 20 percent complete response rate (3 of 15 patients). Eight patients (53 percent) remain progression-free for over one year.

IPI-145 was generally well tolerated, and the majority of side effects were low-grade, asymptomatic and transient. The most common = Grade 3 side effects were increases in ALT or AST (two liver enzymes) (38 percent), neutropenia (31 percent) and diarrhea (13 percent).

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