Md Anderson Cancer Clinic
MD Anderson Cancer Researchers Publish Manuscript on Callisto Pharmaceuticals' Atiprimod in British Cancer Journal
Callisto Pharmaceuticals, Inc. (AMEX: KAL), a
biopharmaceutical company primarily focused on the development of drugs to
treat cancer, announced the publication of a paper in the British Journal
of Cancer on Atiprimod's anti-multiple myeloma activity. The paper,
entitled "Atiprimod Blocks STAT3 Phosphorylation and Induces Apoptosis in
Multiple Myeloma Cells," appeared in the British Journal of Cancer, Volume
92, Number 13, pp.1-11 (2005.), and was authored by a team of scientists
and clinicians from the University of Texas M.D. Anderson Cancer Center,
highly regarded experts in multiple myeloma, blood cancers and
bioimmunotherapy. The publication provides further evidence that Atiprimod
has anti-neoplastic effects on human myeloma cells in culture, and further
elucidated the biological mechanisms by which Atiprimod exerts these
anti-neoplastic effects.
"The team of scientists and clinicians who participated in this study has
an impressive record of advancements in the basic science of blood cancers,
as well as a proven record of success in the clinic," said Dr. Gary S.
Jacob, Chief Executive Officer of Callisto Pharmaceuticals. "Atiprimod is
currently being evaluated at M.D. Anderson in a Phase I/IIa clinical trial
in patients with relapsed multiple myeloma, as well as in a single agent
trial in advanced cancer patients."
In the present work, Atiprimod's effects on proliferation of myeloma cells,
and on the key signaling pathways in myeloma cells were evaluated.
Atiprimod was shown to inhibit proliferation in a time- and dose-dependent
manner, and to arrest myeloma cell growth, preventing cell cycle
progression. Furthermore, Atiprimod inhibited STAT 3 activation, blocking
the signaling pathway of interleukin-6, which contributes to myeloma cell
proliferation and survival. Incubation of myeloma cells with Atiprimod
induced apoptosis (cell death) through the activation of caspase 3, leading
to deactivation of the DNA repair enzyme PARP.
In separate experiments, Atiprimod suppressed myeloma colony-forming cell
proliferation of fresh marrow cells from five patients with newly diagnosed
MM in a dose-dependent fashion.
Atiprimod is currently being evaluated in a Phase I clinical trial in
relapsed or refractory multiple myeloma patients at four clinical sites in
the United States -- the Dana-Farber Cancer Institute (Boston, MA), the
M.D. Anderson Cancer Center (Houston, TX), the St. Vincent's Comprehensive
Cancer Center (New York, NY) and the Roswell Park Cancer Institute
(Buffalo, NY). On May 4, 2005 Callisto announced that three patient cohorts
had completed dosing at 30, 60 and 90 mg, respectively, and a fourth dosing
cohort was underway at 120 mg. No dose limiting toxicities had been
observed, and a fifth dose cohort at 180 mg was anticipated to begin in the
following 6-8 weeks.
About Callisto Pharmaceuticals, Inc.
Callisto is a biopharmaceutical company focused on the development of drugs
to treat cancer. Callisto has two lead drugs in clinical development,
Annamycin to treat relapsed leukemia, and Atiprimod to treat relapsed
multiple myeloma. Callisto intends to initiate a clinical trial of
Annamycin in relapsed acute lymphoblastic leukemia patients in mid 2005.
Annamycin, a drug from the anthracycline family, has a novel therapeutic
profile, including activity against resistant diseases and significantly
reduced cardiotoxicity. 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-K/A for
the year ended December 31, 2004,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.
Investor Relations:
Marty Tullio or Mark Tullio
McCloud Communications, LLC
949.553.9748
Email Contact
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Company Contact:
Dan D'Agostino
Callisto Pharmaceuticals, Inc.
212.297.0010 x227
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