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Sunesis Presents Data on Novel Anti-Cancer Drug at American Association of Cancer Research Meeting

Posted on: Wednesday, 31 March 2004, 06:00 CST

SOUTH SAN FRANCISCO, Calif., March 31 /PRNewswire/ -- Sunesis Pharmaceuticals, Inc. today announced the presentation of two abstracts on the company's lead anti-cancer therapy, SNS-595, at this week's 95th Annual Meeting of the American Association of Cancer Research (AACR). SNS-595 is a novel cytotoxic anti-cancer agent under development to treat solid tumor cancers.

The two abstracts presented were:

-- "ADMET and pharmacokinetic properties of SPC-595 (SNS-595), a

novel cell cycle inhibitory antineoplastic agent in non-clinical

species", and

-- "In vitro and in vivo activity of SPC-595 (SNS-595), a novel cell

cycle inhibitory cytotoxic in murine syngeneic and human xenograft

tumor models".

SNS-595 is a novel naphthyridine compound that induces cell cycle arrest and apoptosis. SNS-595 is cytotoxic toward numerous tumor cell lines including several that are multidrug-resistant. The in vivo antitumor activity of SNS-595 has been investigated in a wide variety of mouse tumor models. SNS-595 showed broad and robust antitumor activity including several drug-resistant models where several currently used drugs show little or no activity. For example, in established sub-cutaneous Colo26 (colorectal) syngeneic tumors, SNS-595 showed a dose-dependent inhibition of tumor growth with clear regressions and complete responses seen at doses at and below its maximum tolerated dose. By comparison, CPT-11 (irinotecan) shows poor activity in this model, resulting in only a delay in tumor growth.

"We are pleased and impressed by the breadth of cytotoxic activity we have observed by SNS-595 in many challenging tumor models," said Daniel Adelman, M.D., Senior Vice President of Development for Sunesis. "In particular, the ability of SNS-595 to outperform existing medicines in these tumor models and to demonstrate activity against drug resistant tumor types points to an important potential opportunity for this product to address a significant unmet need. These data support our plans to initiate Phase I clinical studies in the coming months."

In addition to its excellent efficacy in non-clinical models, SNS-595 exhibits favorable drug-like properties. In vitro studies show that SNS-595 is neither metabolized by, nor inhibits P450 enzymes, shows less than 75 percent serum protein binding across species, does not inhibit the human hERG potassium channel, and does not exhibit any significant off-target activity in a panel of 60 enzymes and receptors. The broad antitumor activity of SNS-595 combined with the activity in drug-resistant models and excellent in vitro ADMET and pharmacokinetic properties warrant clinical investigation of this molecule in humans.

About SNS-595

Sunesis' lead anti-cancer product, SNS-595, is expected to enter human clinical trials in mid-2004. SNS-595 is a cell cycle modulator that arrests the characteristic proliferation of cancer cells by inducing apoptosis, or cell death. In vivo studies of SNS-595 have demonstrated exceptional activity, as well as marked potency in comparison to marketed cytotoxics such as paclitaxel and irinotecan. In addition, SNS-595 has been shown to be highly active in drug-resistant tumor models.

About Sunesis Pharmaceuticals

Sunesis is a biopharmaceutical company that applies proprietary fragment-based drug discovery, Tethering(SM), to create superior small molecule therapeutics for important, yet underserved, diseases. Sunesis is building a pipeline of innovative small molecule drugs addressing the oncology and inflammation markets through internal development and selective partnering. To date, partnerships have been formed with Johnson & Johnson PRD, Merck & Co., Biogen Idec and Dainippon Pharmaceuticals. For further information, visit http://www.sunesis.com/.

Sunesis Pharmaceuticals, Inc.

CONTACT: investors, Eric Bjerkholt, CFO of Sunesis Pharmaceuticals,Inc., +1-650-266-3717; or media, Karen L. Bergman or Michelle Corral, both ofBCC Partners, +1-650-575-1509 or +1-415-794-8662

Web site: http://www.sunesis.com/

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