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Callisto Pharmaceuticals Completes Enrollment of Phase II Trial of Atiprimod in Neuroendocrine Cancer
Date:9/20/2007

NEW YORK, Sept. 20 /PRNewswire-FirstCall/ -- Callisto Pharmaceuticals, Inc. (Amex: KAL; FWB: CA4), a developer of new drug treatments in the fight against cancer and gastrointestinal disorders and diseases, announced today that complete enrollment of its Phase II clinical trial of Atiprimod to treat low to intermediate grade neuroendocrine carcinoma (advanced carcinoid cancer) was accomplished ahead of schedule. The trial, designed to enroll 40 patients, presently has patients enrolled at seven clinical sites in the U.S., and was closed to further enrollment with the addition of the 40th patient.

"This Atiprimod trial was initiated in November, 2006 and we are pleased with the tremendous pace of enrollment that we experienced," said Dr. Gary S. Jacob, Chief Executive Officer of Callisto. "We have patients who have now been on our drug for as long as 11 months, and we expect that by January of 2008 the bulk of patients will have been treated for 6 months or more on our drug. We anticipate at that time releasing interim data from the trial as well as planning for a meeting with FDA on the design of a registration trial."

The primary objective of the Phase II clinical trial was to evaluate efficacy of Atiprimod in patients with low to intermediate grade neuroendocrine carcinoma who have metastatic or unresectable cancer and who have progression of their disease despite standard therapy (octreotide). Patients, after signing an informed consent, were required to complete two weeks of a symptoms diary to establish their symptoms baseline before commencing Atiprimod dosing. Efficacy evaluations include the measure of target lesions (per RECIST), and the quantization of symptom relief. Further details of this trial can be found at http://www.clinicaltrials.gov.

About Atiprimod

Atiprimod is an orally bio-available small molecule drug that displays multiple mechanisms of action. The drug
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SOURCE Callisto Pharmaceuticals, Inc.
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