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Sunesis Pharmaceuticals Initiates Phase II Clinical Trial of

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SNS-595 in Non-Small Cell Lung Cancer

http://www.prnewswire.com/cgi-bin/stori ... 191&EDATE=

SOUTH SAN FRANCISCO, Calif., Jan. 4 /PRNewswire-FirstCall/ -- 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


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