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Callisto Intends to Move Guanilib into Clinical Trials in,Ulcerative Colitis

Announces Positive Data in Animal Models of Ulcerative Colitis

NEW YORK, April 05, 2007 /PRNewswire-FirstCall/ -- Callisto Pharmaceuticals, Inc. , a developer of new drug treatments in the fight against cancer and other major health threats, announced today additional data confirming efficacy of Guanilib, a first-in-class compound currently being developed for the treatment of inflammatory bowel disease (IBD), in two different standard animal models of experimental colitis. Guanilib is an orally deliverable compound designed to mimic a naturally-occurring hormone called uroguanylin. The drug is currently in preclinical development and Callisto intends to move the drug into clinical trials in ulcerative colitis. Guanilib is a proprietary program that was developed in-house by Callisto scientists and the company owns 100% of the worldwide manufacturing and marketing rights.

The new animal data demonstrate that oral administration of Guanilib significantly reduces gastrointestinal (GI) inflammation, and confirm earlier evidence of down-regulation of interleukin-17 (IL-17), IL-23, and tumor necrosis factor (TNF), key cytokines that are known to be involved in etiology of IBD in humans. Guanilib treatment also improved stool consistency and removed intestinal blockage in treated animals.

"These are important findings and suggest a possible mechanism of action of Guanilib and implicate its therapeutic potential in GI inflammatory diseases such as IBD and IBS," said Dr. Kunwar Shailubhai, Senior Vice President, Discovery Research of Callisto, who is also the lead inventor of the issued patent covering therapeutic applications of Guanilib in GI inflammatory diseases and colon cancer.

Callisto believes that Guanilib is presently the best physiological ligand of guanylate cyclase receptor with the potential to provide a new way to treat gastrointestinal diseases, while exhibiting minimal side effects
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