Callisto Pharmaceuticals Opens Additional Site for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
25 Giugno 2007 - 2:00PM
PR Newswire (US)
NEW YORK, June 25 /PRNewswire-FirstCall/ -- Callisto
Pharmaceuticals, Inc. (Amex: KAL; FWB: CA4), a developer of new
drug treatments in the fight against cancer and other major health
threats, announced today the addition of a clinical site to its
Phase II clinical trial of Atiprimod to treat low to intermediate
grade neuroendocrine carcinoma (advanced carcinoid cancer), giving
a total of five open sites. The additional site is the Scott &
White Memorial Hospital, Scott Sherwood and Brindley Foundation,
2401 South 31st Street, Temple, TX 76508. The principal
investigator for the Scott & White Memorial Hospital is Arthur
Frankel, M.D. "The addition of this major cancer center 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. "This site is active in the treatment of neuroendocrine
cancers, which should substantially enhance the pace of enrollment
and increased accessibility to prospective patients interested in
participating in this trial." Currently Callisto has enrolled 23
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 four 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 and 4) Lahey Clinic in Burlington, MA. 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, Callisto Pharmaceuticals, Inc., +1-917-596-9870 Web
site: http://www.callistopharma.com/ http://www.clinicaltrials.gov/
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