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CALLISTO PHARMACEUTICALS ANNOUNCES FILING OF IND
ON ATIPRIMOD FOR MULTIPLE MYELOMA
New York, New York – September 24, 2003 – Callisto Pharmaceuticals,
Inc. (OTCBB: CLSP) today announced the filing of an Investigational New
Drug (IND) application with the U.S. Food and Drug Administration (FDA)
for its cancer drug Atiprimod. The planned Phase I/IIa clinical trial is
an open label study of the safety and efficacy of drug treatment for patients
with refractory or relapsed multiple myeloma. This clinical trial will be
conducted at leading cancer hospitals in the United States. One site will
be The University of Texas M.D. Anderson Cancer Center and will be coordinated
by a leading cancer clinician and investigator, Dr. Moshe Talpaz. The primary
objectives of this clinical trial are to identify the maximum tolerated
dose (MTD) and safety of Atiprimod in multiple myeloma patients. The secondary
objectives are to evaluate the response of relapsed multiple myeloma patients,
measure the drug pharmacokinetics and evaluate a wide variety of surrogate
markers to better define the mechanisms of action for Atiprimod. "The
filing of this IND is a significant milestone for Callisto. We are very
excited about the potential of Atiprimod to treat multiple myeloma patients,” says
Dr.
Gary S. Jacob, CEO of Callisto Pharmaceuticals, Inc.
Multiple myeloma is a common hematological malignancy (10% of all hematological
cancers) and represents 1% of all cancer malignancies. There are currently
approximately 50,000 patients in the U.S. with approximately 15,000 newly
diagnosed patients yearly. Despite 3 decades of clinical trial research
involving thousands of patients with multiple myeloma and the recent approval
of new drugs, the disease continues to be fatal to the majority of patients.
Atiprimod is a drug that has completed a Phase
I/IIa clinical trial in rheumatoid arthritis patients with patient
dosing as long as 1 year. The
drug is now entering clinical trials in multiple myeloma based
on a wide range of compelling preclinical data for this particular
cancer. Atiprimod
has also shown potent activity against a wide range of solid tumors
in in-vitro screens and will be evaluated in animal models of
solid tumors to expand
Atiprimod’s clinical trial indications. Callisto has an exclusive
worldwide license from AnorMED Inc. to develop, manufacture, use
and sell Atiprimod.
About Callisto Pharmaceuticals, Inc.
Callisto is a biopharmaceutical company primarily focused on the
development of drugs to treat multiple myeloma, other cancers
and osteolytic bone disease. Callisto’s lead drug candidate, Atiprimod, is a small-molecule,
orally available drug with antiproliferative and antiangiogenic activity.
Callisto’s second anticancer program is focused on the development
of an analog of the human intestinal hormone, uroguanylin, to
treat colon cancer. Callisto has two operating subsidiaries,
Callisto Research Labs,
LLC and Synergy Pharmaceuticals Inc.
Included in this release are “forward-looking: statements. 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 have been correct. Callisto’s
actual results could differ materially from those anticipated in
the forward-looking statements as a result of various factors.
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