Sunesis Pharmaceuticals Files Investigational New Drug Application for Novel Aurora Kinase Inhibitor, SNS-314

Announced today that the company has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for SNS-314, an internally-developed anticancer product candidate

Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS), announced today that the company has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for SNS-314, an internally-developed anticancer product candidate. SNS-314 is a targeted small molecule that selectively inhibits the Aurora kinases. Aurora kinases are key enzymes involved in cancer cell growth and division, and have a central role in the abnormal growth and proliferation of tumor cells.

"We are pleased to be advancing our third oncology program into the clinic with the filing of this IND for our Aurora kinase inhibitor, SNS-314. We anticipate treating patients with advanced solid tumors in the second quarter," said Daniel Swisher, Sunesis' Chief Executive Officer and President. "SNS-314 was discovered using Sunesis' integrated discovery science platform, resulting in what we believe is a potential 'best-in-class' compound."

"We look forward to initiating clinical studies of SNS-314, which has demonstrated strong anti-proliferative activity across a number of different tumor models," said Daniel Adelman, M.D., Senior Vice President, Research and Development at Sunesis. "In particular, we are pleased to see that SNS-314 behaves selectively and specifically against Aurora kinases. With SNS-314, we have observed robust, dose-dependent activity under multiple dosing schedules, which should provide greater dosing flexibility in the clinic than competitor candidates. In our first Phase 1 study, we plan to dose SNS-314 intravenously on a weekly basis."

Discovered by Sunesis using Tethering(R), the company's fragment-based discovery engine, SNS-314 is a potent and selective inhibitor of Aurora kinases A, B, and C. SNS-314 targets the uncontrolled cellular proliferation associated with cancer by halting cell division at the mitotic phase of the cell cycle. In nonclinical studies, SNS-314 has demonstrated robust anti- tumor activity on an intermittent dosing schedule across diverse tumor models. Based on the broad nonclinical activity observed in xenograft models, Sunesis plans to initially evaluate SNS-314 as a single agent in patients with advanced solid tumor malignancies.

About Sunesis' Oncology Programs

Sunesis has built a rich portfolio of product candidates in oncology focused on novel pathways and targets, including inhibition of the cell-cycle and survival signaling. Sunesis is currently conducting Phase 2 and Phase 1 clinical trials in lung cancer, ovarian cancer and acute myeloid leukemia for its lead compound, SNS-595. The company is evaluating SNS-032, its CDK inhibitor compound, in a Phase 1/2 clinical trial to examine safety and preliminary anti-tumor activity. SNS-314 is expected to begin Phase 1 clinical trials in the first half of 2007. In addition, in cooperation with Biogen Idec, Sunesis is developing novel small molecule inhibitors of Raf kinase and other oncology kinases.

About Sunesis Pharmaceuticals

Sunesis is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule therapeutics for oncology and other serious diseases. Sunesis has built a broad product candidate portfolio through internal discovery and in-licensing of targeted cancer therapeutics. Sunesis is advancing its product candidates through in-house research and development efforts and strategic collaborations with leading pharmaceutical and biopharmaceutical companies.

Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties. Sunesis may not actually achieve the plans, intentions or expectations contained in such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations contained in such forward-looking statements. Sunesis does not assume any obligation to update any such forward-looking statements. For further information on Sunesis Pharmaceuticals, please visit

SOURCE Sunesis Pharmaceuticals, Inc

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