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Infinity Pharmaceuticals Inc Announces Updated Phase 1 Data Showing Encouraging Clinical Activity of IPI-145 in Chronic Lymphocytic Leukemia

Sunday, 2 Jun 2013 09:00am EDT 

Infinity Pharmaceuticals Inc 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 chronic lymphocytic leukemia (CLL), a potentially fatal hematologic malignancy, or blood cancer. Data from the study showed that IPI-145 was well tolerated, with a rapid onset of clinical activity. Based on the tolerability and activity profile of IPI-145 observed to date, Infinity also announced that it has initiated a new expansion cohort within its ongoing Phase 1 study to evaluate the safety, activity and pharmacokinetics (PK) of IPI-145 dosed at 25 mg twice daily (BID) as treatment for patients with newly diagnosed, high-risk CLL. 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 either the total safety population or in patients with CLL. Adverse events were primarily managed by dose interruptions and reductions. Among CLL patients enrolled in the study, the most frequent Grade 3/4 adverse event was neutropenia. Grade 3 and Grade 4 neutropenia occurred in five (15% of) and eight (24% of) patients, respectively. The majority of neutropenia observed did not require dose reductions. 

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