Callisto Pharmaceuticals Completes Enrollment of Phase II Trial of Atiprimod in Neuroendocrine Cancer
20 Septiembre 2007 - 6:07AM
PR Newswire (US)
NEW YORK, Sept. 20 /PRNewswire-FirstCall/ -- Callisto
Pharmaceuticals, Inc. (Amex: KAL; FWB: CA4), a developer of new
drug treatments in the fight against cancer and gastrointestinal
disorders and diseases, announced today that complete enrollment of
its Phase II clinical trial of Atiprimod to treat low to
intermediate grade neuroendocrine carcinoma (advanced carcinoid
cancer) was accomplished ahead of schedule. The trial, designed to
enroll 40 patients, presently has patients enrolled at seven
clinical sites in the U.S., and was closed to further enrollment
with the addition of the 40th patient. "This Atiprimod trial was
initiated in November, 2006 and we are pleased with the tremendous
pace of enrollment that we experienced," said Dr. Gary S. Jacob,
Chief Executive Officer of Callisto. "We have patients who have now
been on our drug for as long as 11 months, and we expect that by
January of 2008 the bulk of patients will have been treated for 6
months or more on our drug. We anticipate at that time releasing
interim data from the trial as well as planning for a meeting with
FDA on the design of a registration trial." The primary objective
of the Phase II clinical trial was 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, were required to
complete two weeks of a symptoms diary to establish their symptoms
baseline before commencing Atiprimod dosing. Efficacy evaluations
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/. 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 DATASOURCE: Callisto
Pharmaceuticals, Inc. CONTACT: Gary Jacob of Callisto
Pharmaceuticals, Inc., +1-212-297-0010, Web site:
http://www.callistopharma.com/ http://www.clinicaltrials.gov/
Copyright