Surgery News

Transition commences dosing in TT-301 Phase 1 clinical study for rheumatoid arthritis, ICH, TBI

November 30, 2015

CAL-101, the Company's oral, delta selective PI3K inhibitor, has demonstrated promising anti-tumor activity in a single agent Phase 1 clinical trial involving more than 100 patients with hematologic malignancies. Results presented in June 2010 at the American Society of Clinical Oncology annual meeting demonstrated that single agent CAL-101 treatment in patients with relapsed or refractory indolent non-Hodgkin's lymphoma (iNHL), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL) resulted in overall response rates of 57 percent, 67 percent and 30 percent, respectively. Furthermore, 94 percent of patients with CLL had greater than 50 percent decrease in their lymph node disease, demonstrating a high degree of biologic activity. Overall, CAL-101 was generally well tolerated. A low incidence of hematological toxicity was observed. Some patients had an asymptomatic elevation of transaminases, which was monitorable and reversible following discontinuation of dosing. Most patients resumed CAL-101 at a reduced dose.

CAL-101 is a first-in-class inhibitor of the PI3K delta isoform. It is an orally administered small molecule, and exhibits a greater than 200-fold selectivity in cell-based assays for the delta isoform as compared to other class 1 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. In addition to CAL-101, Calistoga Pharmaceuticals' pipeline of isoform-selective PI3K inhibitors includes CAL-263, a delta isoform-selective PI3K inhibitor for treatment of patients with inflammatory diseases such as asthma, chronic obstructive pulmonary disease and rheumatoid arthritis.

SOURCE Calistoga Pharmaceuticals