Callisto Reports on Second-Quarter 2007 Milestones
08 Agosto 2007 - 7:00AM
PR Newswire (US)
Company Cites Continuing Progress on Clinical and Preclinical
Programs NEW YORK, Aug. 8 /PRNewswire-FirstCall/ -- Callisto
Pharmaceuticals, Inc. (Amex: KAL; FWB: CA4), a developer of new
drug treatments in the fight against cancer and gastrointestinal
diseases, is pleased to provide an update covering its strategic
and drug development activities for the second quarter of 2007.
"Callisto has made substantial progress with our clinical and
preclinical programs in 2007," stated Gary S. Jacob, CEO of
Callisto Pharmaceuticals. "In particular, the pace of our Phase II
clinical trial of Atiprimod in neuroendocrine cancer patients
continues to go well, and we expect to have full enrollment
accomplished by the third quarter of 2007. " The Atiprimod Phase II
clinical trial in neuroendocrine carcinoma is a multiple-center,
open-label study of the safety and efficacy of Atiprimod in low to
intermediate grade neuroendocrine carcinoma patients. The trial,
designed to enroll 40 patients, presently has 29 patients on study,
and Callisto anticipates achieving the total enrollment of 40
patients in the third quarter of 2007. The trial was opened in
November, 2006 and there are presently 5 clinical sites in the U.S.
that are enrolling patients. The Company plans to have discussions
with FDA some time in the fourth quarter of 2007 regarding the
design of a pivotal trial in this disease indication. Dr. Jacob
continued, "We also have implemented a plan to develop Guanilib,
Callisto's guanylyl cyclase C receptor agonist, to treat
gastrointestinal disorders such as chronic constipation and
irritable bowel syndrome. We plan to file an Investigational New
Drug application with FDA in early 2008, and evaluate its potential
initially in gastrointestinal disorders where there is a critical
need for new drugs to treat the millions of patients currently
suffering from these maladies." About Guanilib Guanilib (also
called SP-304) is a potent analog (synthetic molecule) of
uroguanylin developed by Callisto scientists, and is proprietary to
Callisto. Guanilib has been demonstrated to be superior to
uroguanylin in its biological activity, protease stability and pH
characteristics, and is currently undergoing pre-clinical animal
studies as a treatment for gastrointestinal (GI) diseases and GI
inflammation. Animal model data on Guanilib previously demonstrated
anti-inflammatory activity in a number of mouse-models of
ulcerative colitis, and the drug is currently being evaluated in
animal models of GI disorders. Callisto plans to initiate clinical
trials of Guanilib in early 2008. About Atiprimod Atiprimod is an
orally bio-available small molecule drug that displays multiple
mechanisms of action. The drug has been shown to be antiangiogenic,
inhibit secretion of VEGF and IL-6, elicit an apoptotic response
(programmed cellular death), and inhibit phosphorylation of key
kinases involved in tumor progression and survival including Akt
and STAT3. The drug is presently in two clinical trials: a Phase II
trial in advanced carcinoid cancer patients, and a Phase I/IIa
human clinical trial in relapsed or refractory multiple myeloma
patients. About Callisto Pharmaceuticals, Inc. Callisto is a
biopharmaceutical company focused on the development of new drugs
to treat various forms of cancer and gastrointestinal diseases.
Callisto's drug candidates in development currently include
anti-cancer agents in clinical development, in addition to drugs in
pre-clinical development for other significant health care markets,
including gastrointestinal disorders. One of the Company's lead
drug candidates, Atiprimod is presently in a Phase II clinical
trial in advanced carcinoid cancer patients, a neuroendocrine
tumor, and in a Phase I/IIa human clinical trial in relapsed or
refractory multiple myeloma patients. Another anti-cancer drug,
L-Annamycin, is being developed as a treatment for forms of
relapsed or refractory acute leukemia, a currently incurable blood
cancer. L-Annamycin is currently in a Phase I clinical trial in
adult relapsed or refractory acute lymphocytic leukemia, and in a
Phase I clinical trial in children and young adults with refractory
or relapsed acute lymphocytic leukemia or acute myelogenous
leukemia. L- Annamycin, a member of the anthracycline family of
proven anti-cancer drugs, has a novel therapeutic profile,
including potential activity against multi- drug resistant tumors
and significantly reduced cardiotoxicity, or damage to the heart,
compared to currently available drug alternatives. Callisto also
has a proprietary drug Guanilib in preclinical development for
gastro- intestinal disorders. Callisto has exclusive worldwide
licenses from Genzyme 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 is available
at http://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 for the year ended
December 31, 2006, 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. CONTACT: Gary Jacob of Callisto
Pharmaceuticals, Inc., +1-212-297-0010, Web site:
http://www.callistopharma.com/ Barretto Pacific Corporation John
Baldissera 800-368-1217 DATASOURCE: Callisto Pharmaceuticals, Inc.
CONTACT: Gary Jacob of Callisto Pharmaceuticals, Inc.,
+1-212-297-0010, ; or John Baldissera of Barretto Pacific
Corporation, 1-800-368-1217, for Callisto Pharmaceuticals, Inc. Web
site: http://www.callistopharma.com/
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