Calistoga announced the initiation of its Phase 2 combination trial of CAL-101 plus Rituxan (rituximab) in previously untreated, elderly patients with chronic lymphocytic leukemia (CLL). This trial will enroll up to 60 patients ≥65 years of age with CLL or small lymphocytic lymphoma (SLL). Patients will receive treatment with rituximab, administered in 8 weekly doses, together with oral CAL-101, administrated twice daily; they will not take chemotherapy as part of the regimen. Patients will remain on CAL-101 therapy as long as they continue to benefit. The trial is designed to evaluate the safety and clinical activity of the new combination treatment.

CAL-101 is an orally administered small molecule, first-in-class inhibitor of the Phosphoinositide 3-kinases (PI3K) delta isoform. It exhibits greater than 200-fold selectivity in cell-based assays for the delta isoform as compared to other PI3K isoforms. CAL-101 is designed to induce cancer cell death (apoptosis) and to inhibit the signaling pathways associated with cancer cell dependence on the tumor microenvironment.

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