Inc. (Amex: KAL)(FWB:CA4), a developer of new drug treatments in the fight
against cancer and other major health threats, announced today the
publication of two research articles on Atiprimod, Callisto's drug
currently in clinical trials in multiple myeloma and advanced cancer
patients, in the current issue of Leukemia Research, a peer-reviewed
scientific journal that publishes original research articles related to
leukemia and other myeloid malignancies.
The first of the two articles co-authored by a group of established
researchers from the University of Texas M.D. Anderson Cancer Center
focuses on Atiprimod's ability to inhibit proliferation of acute myeloid
leukemia (AML) cells from marrow samples of healthy volunteers. The second
article, authored by Dr. Kunwar Shailubhai, Sr. VP Discovery Research,
Callisto Pharmaceuticals, describes possible mechanisms of action of
Atiprimod in myeloid and other human malignancies. These articles strongly
suggest that anti-cancer actions of Atiprimod could be via inhibition of
JAK-STAT and the downstream Akt signaling pathways, which are important
targets for cancer intervention, and which further support clinical
evaluation of Atiprimod in human cancer patients.
Atiprimod is an orally bio-available small molecule drug that displays
multiple mechanisms of action. The drug is presently in a Phase I/IIa human
clinical trial in relapsed or refractory multiple myeloma patients, and in
a Phase I/IIa trial in advanced cancer patients. Callisto earlier announced
in June interim data from the Phase I trial of Atiprimod in advanced cancer
patients. The patients who were entered into this trial had growing tumors
and symptoms that were no longer controlled by the standard therapies
utilized. During treatment, three of the five advanced carcinoid patients
had measurable tumor regressions and loss of many of the debilitating
symptoms of this disease. Based on these data, Callisto announced on June
27 its intention to initiate a single-agent Phase II clinical trial of
Atiprimod in advanced carcinoid cancer patients.
The two publications appeared in Leukemia Research, Jul 21 and Jul 6
[Epub ahead of print]
ipr imod) (2006) and are titled: "Atiprimod blocks phosphorylation of
JAK-STAT and inhibits proliferation of acute myeloid leukemia (AML) cells"
by S. Faderl, A. Ferrajoli, D. Harris, Q. Van, H. M. Kantarjian, and Z.
Estrov, and "Atiprimod: a multi-functional drug candidate for myeloid and
other malignancies" by K. Shailubhai.
About Callisto Pharmaceuticals, Inc.
Callisto is a biopharmaceutical company focused on the development of
new drugs to treat various forms of cancer and other serious afflictions.
Callisto's drug candidates in development currently include anti-cancer
agents in clinical development, in addition to drugs for other significant
health care markets, including ulcerative colitis and biodefense. One of
the Company's lead drug candidates, L-Annamycin, is being developed as a
treatment for forms of relapsed acute leukemia, a currently incurable blood
cancer. Callisto initiated a clinical trial of L-Annamycin in adult
relapsed acute lymphocytic leukemia patients in 4Q 2005. L-Annamycin, a new
compound from the anthracycline family of proven anti-cancer drugs, has a
novel therapeutic profile, including activity against resistant diseases
and significantly reduced cardiotoxicity, or damage to the heart, compared
to currently available drug alternatives. Another anti-cancer drug,
Atiprimod, is in development to treat relapsed multiple myeloma, a blood
cancer, and advanced carcinoid cancer. Atiprimod is presently in Phase
I/IIa human clinical trials in relapsed multiple myeloma patients, and
advanced cancer patients, respectively. Callisto also has drugs in
preclinical development for gastro- intestinal 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 L-Annamycin, respectively. Callisto is also
listed on the Frankfurt Stock Exchange under the ticker symbol CA4, more
information at http://www.callistopharma.com.
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, 2005, 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.
Callisto Pharmaceuticals, Inc
Publication Date: 2006-10-11 02:00