IPI-145 is a potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. The PI3K-delta and PI3K-gamma isoforms are preferentially expressed in leukocytes (white blood cells), where they have distinct and non-overlapping roles in key cellular functions, including cell proliferation, cell differentiation, cell migration and immunity. Targeting PI3K-delta and PI3K-gamma may provide multiple opportunities to develop differentiated therapies for the treatment of blood cancers and inflammatory diseases.
We are currently enrolling patients in Phase 2 study designed to evaluate the activity and safety of IPI-145 in approximately 120 people with refractory indolent non-Hodgkin lymphoma (iNHL). By the end of 2013, we also expect to begin a Phase 3 clinical study of IPI-145 in approximately 300 people with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). These studies are supported by Phase 1 data reported at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting which showed that IPI-145 was well tolerated and clinically active in a broad range of malignancies, including iNHL and CLL/SLL.
Additionally, we are continuing to explore the safety, activity and pharmacokinetics of IPI-145 in the expansion portion of a Phase 1, open-label, study in people with advanced blood cancers. The expansion cohorts include people with the following hematologic malignancies:
- iNHL chronic lymphocytic leukemia (CLL) and mantle cell lymphoma
- T-cell lymphomas
- Aggressive B-cell lymphomas
- Myeloid neoplasms
- T-cell or B-cell acute lymphoblastic leukemia/lymphoma
- Treatment-naïve, high-risk CLL
We are also studying IPI-145 for the treatment of inflammatory diseases. We are conducting a Phase 2a, randomized, double-blind, placebo-controlled study of IPI-145 in approximately 30 people with mild, allergic asthma as well as a Phase 2 study of IPI-145 in approximately 300 adults with rheumatoid arthritis.