Sunesis Pharmaceuticals, Inc. has commenced patient treatment in a Phase II clinical trial of SNS-595, the company's lead anti-cancer therapeutic, in patients with non-small cell lung cancer.

The trial is an open-label, multi-centre study designed to examine the safety and efficacy of SNS-595 as a second-line agent in patients with non-small cell lung cancer who have failed first-line platinum-based therapy. SNS-595 is a first-in-class cell-cycle modulator that kills proliferating cancer cells by inducing apoptosis, or programmed cell death, as cells progress through the S phase of the cell cycle.

"The commencement of this Phase II trial for SNS-595 builds on the encouraging results observed in our Phase I clinical trials in patients with advanced solid tumours, exploring the potential benefit of SNS-595 for patients with lung cancer in a second-line setting," said Daniel Adelman, MD, Senior Vice President of Research and Development at Sunesis. "First-line treatment in non-small cell lung cancer typically includes a platinum drug, such as carboplatin, in combination with a taxane. SNS-595 has shown potent anti- tumour activity in pre-clinical platinum-resistant NSCLC tumour models," added Dr. Adelman.

Patients with non-small cell lung cancer who have failed first-line treatment will be enrolled at multiple centres in the United States. Eligible patients will receive SNS-595 every three weeks at the maximum tolerated dose for heavily pre-treated patients identified in Phase I.

The start of this trial triggered a $0.5 million milestone payment to Dainippon Sumitomo Pharma Co., Ltd., in accordance with the terms of the 2003 license agreement between Sunesis and Dainippon.