Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
09 Agosto 2007 - 7:00AM
PR Newswire (US)
NEW YORK, Aug. 9 /PRNewswire-FirstCall/ -- Callisto
Pharmaceuticals, Inc. (Amex: KAL; FWB: CA4), a developer of new
drug treatments in the fight against cancer and inflammatory
diseases, announced today the addition of two sites to its Phase II
clinical trial of Atiprimod to treat low to intermediate grade
neuroendocrine carcinoma (advanced carcinoid cancer). With the
addition of the Robert H. Lurie Comprehensive Cancer Center of
Northwestern University, 676 N. St. Clair Street, Suite 850,
Chicago, IL and the H. Lee Moffitt Cancer Center & Research
Institute, 12902 Magnolia Drive, Tampa, FL 33612, the Phase II
clinical trial is presently being conducted in seven sites. The
principal investigator for Northwestern is Mary Mulcahy, MD, and
the principal investigator for Lee Moffitt is Larry K. Kvols, M.D.
"The addition of these two major cancer centers to the Phase II
trial of Atiprimod in advanced carcinoid patients signifies our
continuing commitment to facilitate rapid enrollment of this
trial," said Dr. Gary S. Jacob, Chief Executive Officer of
Callisto. "Both sites are active in the treatment of neuroendocrine
cancers, and have built significant reputations within the
carcinoid community, which should substantially enhance the pace of
enrollment and increased accessibility to prospective patients
interested in participating in this trial." Currently Callisto has
enrolled 31 patients of the 40 subjects planned for this Phase II
clinical trial. The primary objective of the Phase II clinical
trial is to evaluate efficacy of Atiprimod in patients with low to
intermediate grade neuroendocrine carcinoma who have metastatic or
unresectable cancer and who have progression of their disease
despite standard therapy (octreotide). Patients, after signing an
informed consent, are required to complete two weeks of a symptoms
diary to establish their symptoms baseline before commencing
Atiprimod dosing. A maximum of 40 evaluable patients will be
enrolled in this trial. Efficacy evaluations will include the
measure of target lesions (per RECIST), and the quantization of
symptom relief. Further details of this trial can be found at
http://www.clinicaltrials.gov/. The other five sites currently
participating in this Phase II trial are: 1) the Hematology
Oncology Services of Arkansas in Little Rock, Arkansas, 2) the
Dana-Farber Cancer Institute in Boston, MA. 3) Mount Sinai in New
York City, 4) Lahey Clinic in Burlington, MA. and 5) Scott &
White Memorial Hospital in Temple TX. 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. Callisto earlier announced in June, 2006 interim data
from a 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. About Carcinoid Cancer
Carcinoid tumors, or carcinoids, originate in hormone-producing
cells of the gastrointestinal (GI) tract, the respiratory tract,
the hepatobiliary (liver) system and the reproductive glands. The
most common site of origin is the GI tract, with tumors often
developing in the rectum, and other sections of the small
intestine. Approximately 7,000 cases of carcinoid cancer are
diagnosed in the U.S. annually, with the number increasing over the
past 20-30 years. Carcinoid tumors that metastasize to the liver
have a poor prognosis. Traditionally, chemotherapy relieves
symptoms in less than 30% of cases of metastatic carcinoid tumors,
usually for less than 1 year. Carcinoid tumors typically produce a
condition called "carcinoid syndrome" which is caused by the
release of hormones by the tumors into the blood stream. The
symptoms vary depending on which hormones are released by the
tumors, but typically include diarrhea, facial flushing, wheezing,
abdominal pain and valvular heart disease. 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 , or John Baldissera of
Barretto Pacific Corporation, +1-800-368-1217, for Callisto
Pharmaceuticals, Inc. Web site: http://www.callistopharma.com/
http://www.clinicaltrials.gov/
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