Callisto Reports on Second-Quarter 2007 ...( Company Cites Continuing Progress ...),Health

Company Cites Continuing Progress on Clinical and Preclinical Programs

NEW YORK, Aug. 8 /PRNewswire-FirstCall/ -- Callisto Pharmaceuticals, Inc. (Amex: KAL; FWB: CA4), a developer of new drug treatments in the fight against cancer and gastrointestinal diseases, is pleased to provide an update covering its strategic and drug development activities for the second quarter of 2007.

"Callisto has made substantial progress with our clinical and preclinical programs in 2007," stated Gary S. Jacob, CEO of Callisto Pharmaceuticals. "In particular, the pace of our Phase II clinical trial of Atiprimod in neuroendocrine cancer patients continues to go well, and we expect to have full enrollment accomplished by the third quarter of 2007. "

The Atiprimod Phase II clinical trial in neuroendocrine carcinoma is a multiple-center, open-label study of the safety and efficacy of Atiprimod in low to intermediate grade neuroendocrine carcinoma patients. The trial, designed to enroll 40 patients, presently has 29 patients on study, and Callisto anticipates achieving the total enrollment of 40 patients in the third quarter of 2007. The trial was opened in November, 2006 and there are presently 5 clinical sites in the U.S. that are enrolling patients. The Company plans to have discussions with FDA some time in the fourth quarter of 2007 regarding the design of a pivotal trial in this disease indication.

Dr. Jacob continued, "We also have implemented a plan to develop Guanilib, Callisto's guanylyl cyclase C receptor agonist, to treat gastrointestinal disorders such as chronic constipation and irritable bowel syndrome. We plan to file an Investigational New Drug application with FDA in early 2008, and evaluate its potential initially in gastrointestinal disorders where there is a critical need for new drugs to treat the millions of patients currently suffering from these maladies."

About Guanilib

Guanilib (also called SP-304) is a potent analog (synt
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SOURCE Callisto Pharmaceuticals, Inc. Copyright©2007 PR Newswire.

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