Published:
Callisto Pharmaceuticals Announces Additional Clinical Trial Sites for Atiprimod
Company's Cancer Drug Now Under Clinical Trial at Four Leading Cancer Research Institutions

Callisto Pharmaceuticals, Inc. , a
biopharmaceutical company primarily focused on the development of drugs to
treat cancer and osteolytic bone disease, announced today the opening of
two additional sites for the Phase I/IIa clinical trial of Atiprimod. The
new sites include the Roswell Park Cancer Institute in Buffalo, New York
and the St. Vincent's Comprehensive Cancer Center in New York, NY.
Atiprimod is Callisto's lead drug candidate for treatment of multiple
myeloma (MM). The trial is presently underway at two leading cancer
centers in the United States, the Dana-Farber Cancer Institute in Boston,
Massachusetts, and The University of Texas M. D. Anderson Cancer Center,
Houston, Texas.
"We are pleased to announce the addition of these two sites at Roswell Park
and St. Vincent Hospital to our Atiprimod clinical trial," said Callisto
Executive VP, R&D Dr. Donald Picker. "The new sites, both of which are
leading institutions for the study of cancer and bone disease, will provide
additional patients for the ongoing trial."
The primary objective of the Phase I/IIa trial is to provide additional
data for the identification of the maximum tolerated dose of Atiprimod in
patients. The secondary objectives are to provide additional data on 1)
the measurement of its pharmacokinetics, 2) the response to Atiprimod in
patients with relapsed multiple myeloma, and 3) the screening of surrogate
markers to explore any potential drug effect in multiple myeloma patients.
About Callisto Pharmaceuticals, Inc.
Callisto is a biopharmaceutical company focused on the development of drugs
to treat cancer and osteolytic bone disease. Callisto recently in-licensed
Annamycin, a drug to treat leukemia, based on the drug's novel therapeutic
profile, including activity against resistant diseases and significantly
reduced toxicity. Callisto intends to initiate a Phase IIb clinical trial
of Annamycin in relapsed acute lymphocytic leukemia patients in the first
half of 2005. Callisto's second drug, Atiprimod, is in a Phase I/IIa
clinical trial in relapsed multiple myeloma patients, and is a
small-molecule, orally available drug with antiproliferative and
antiangiogenic activity. Callisto also has drugs in preclinical
development for melanoma, gastrointestinal inflammation, and a program
focused on the development of a drug to protect against staphylococcus and
streptococcus biowarfare agents. Callisto has exclusive worldwide licenses
from AnorMED Inc. and M.D. Anderson Cancer Center to develop, manufacture,
use and sell Atiprimod and Annamycin, respectively. For additional
information, visit www.callistopharma.com.
Forward-Looking Statements
Certain statements made in this press release are forward looking. Such
statements are indicated by words such as "expect," "should," "anticipate"
and similar words indicating uncertainty in facts and figures. Although
Callisto believes that the expectations reflected in such forward-looking
statements are reasonable, it can give no assurance that such expectations
reflected in such forward-looking statements will prove to be correct. As
discussed in the Callisto Pharmaceuticals Annual Report on Form 10-KSB for
the year ended December 31, 2003,and other periodic reports, as filed with
the Securities and Exchange Commission, actual results could differ
materially from those projected in the forward-looking statements as a
result of the following factors, among others: uncertainties associated
with product development, the risk that products that appeared promising in
early clinical trials do not demonstrate efficacy in larger-scale clinical
trials, the risk that Callisto will not obtain approval to market its
products, the risks associated with dependence upon key personnel and the
need for additional financing.
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