Callisto Pharmaceuticals Opens Fourth Site for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
24 Maggio 2007 - 4:00PM
PR Newswire (US)
NEW YORK, May 24 /PRNewswire-FirstCall/ -- Callisto
Pharmaceuticals, Inc. (Amex: KAL; FWB: CA4), a developer of new
drugs for the treatment of cancer and inflammatory diseases,
announced today the addition of Lahey Clinic in Burlington, MA to
its Phase II clinical trial of Atiprimod to treat low to
intermediate grade neuroendocrine carcinoma (advanced carcinoid
cancer). The Principal Investigator at this clinical site is Keith
Stuart, MD. Other major cancer centers are currently reviewing the
trial protocol, and the Company anticipates additional sites will
be added to the trial. "The addition of the Lahey Clinic 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. "The Lahey Clinic specializes in the treatment of
neuroendocrine cancers, and has built a significant reputation
within the carcinoid community, which should substantially enhance
the pace of enrollment and increased accessibility to prospective
patients interested in participating in this 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 three 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,
and 3) Mount Sinai in New York, NY. 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 other serious afflictions. 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 ulcerative
colitis. One of the Company's lead drug candidates, Atiprimod, is
in development to treat advanced carcinoid cancer, a neuroendocrine
tumor, and relapsed multiple myeloma, a blood cancer. Atiprimod is
presently in a Phase II clinical trial in advanced carcinoid cancer
patients, and in Phase I/IIa human clinical trials in relapsed or
refractory multiple myeloma patients, and advanced cancer patients,
respectively. 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. Callisto initiated a
clinical trial of L- Annamycin in adult relapsed or refractory
acute lymphoblastic 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. Callisto also has drugs in preclinical development
for gastro-intestinal inflammation, and cancer. 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 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/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. DATASOURCE: Callisto Pharmaceuticals, Inc. CONTACT: Dan
D'Agostino of Callisto Pharmaceuticals, Inc., +1-212-297-0010, ext.
227, or Web site: http://www.callistopharma.com/
http://www.clinicaltrials.gov/
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