News Release

<< Back

Sunesis Pharmaceuticals Initiates Phase II Clinical Trial of SNS-595 in Non-Small Cell Lung Cancer

01/04/06

SOUTH SAN FRANCISCO, Calif., Jan 04, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced that patient treatment has commenced 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-center 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 tumors, 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- tumor activity in pre-clinical platinum-resistant NSCLC tumor models," added Dr. Adelman.

Patients with non-small cell lung cancer who have failed first-line treatment will be enrolled at multiple centers 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.

About SNS-595

SNS-595 is a first-in-class cytotoxic with a novel mechanism of action. SNS-595 acts during the S phase of the cell cycle to induce rapid apoptosis of cells that are actively synthesizing DNA. In clinical trials conducted to date, SNS-595 has been well tolerated and has shown promising signs of clinical activity. In addition, SNS-595 has exhibited broad activity in xenograft studies and drug-resistant tumor models.

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 novel 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 http://www.sunesis.com.

SOURCE Sunesis Pharmaceuticals, Inc.

investors, Eric Bjerkholt, CFO of Sunesis Pharmaceuticals, Inc., +1-650-266-3717; or
media, Karen L. Bergman or Michelle Corral, both of BCC Partners, +1-650-575-1509, or
+1-415-794-8662, for Sunesis Pharmaceuticals, Inc.
http://www.prnewswire.com

Copyright (C) 2006 PR Newswire. All rights reserved.

News Provided by COMTEX