The third oncology program for Sunesis Pharmaceuticals to advance to the clinic, SNS-314 was filed as an Investigational New Drug (IND) with the FDA at the beginning of March.

    SNS-314 inhibits Aurora kinases A, B, and C. Stopping Aurora kinases halts cellular division at the mitotoic phase of the cell cycle. Preclinical studies of SNS-314 in mice tumor models have shown broad anti-tumor activity, and Sunesis plans to initially evaluate SNS-314 as a single agent in patients with advanced solid tumors in phase I clinical trials in the upcoming months. Sunesis also has SNS-595, a cell cycle inhibitor, in clinical phase II trials for lung cancer, ovarian cancer, and leukemiaterm.

Sunesis Pharmaceuticals, Inc. today announced that the company will advance the small-cell lung cancer trial in treatment-sensitive patients to Stage 2. The company reported initial results from the first stages of two Phase 2 clinical trials of SNS-595, a novel cell-cycle inhibitor, in first- line relapsed/refractory small cell and non-small cell lung cancers. Anti- tumor activity was observed, including evidence of stable disease, minor responses and partial responses reported in one arm of the small cell lung cancer study, and minor and mixed responses and stable disease in the non- small cell lung cancer trial. Sunesis initiated the Phase 2 studies of SNS-595 in small cell lung cancer and non-small cell lung cancer in 2006 to evaluate the compound's activity as a single agent in the second-line treatment setting. Both clinical trials utilized a two-stage design, enabling an interim assessment of clinical activity in order to determine next steps for the compound's evaluation in each tumor indication. All patients received doses of 48 mg/m2 every three weeks, the maximum-tolerated dose identified in Phase 1 clinical trials. Consistent with prior findings, SNS-595 was generally well-tolerated. Sunesis' Phase 2 small cell lung cancer clinical trial included two arms of relapsed or refractory patients -- treatment sensitive and treatment refractory. With nine of eleven evaluable patients in the treatment-sensitive arm of the trial having stable disease or objective responses by the end of two cycles of treatment, the clinical results have exceeded the pre-specified requirement of at least two partial or complete responses in the first 20 evaluable patients for advancing to Stage 2. Based on the interim data analysis reported today, Sunesis plans to continue Phase 2 clinical evaluation of SNS-595 in treatment-sensitive small cell lung cancer patients who had previously responded to first-line therapy, but subsequently relapsed after more than three months.