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Callisto Pharmaceuticals Opens Fourth Site For Phase II Clinical Trial Of Atiprimod In Advanced Carcinoid Cancer Patients
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.
Callisto Pharmaceuticals, Inc.
http://www.callistopharma.com
Callisto produse farmaceutice deschide site-ul pentru al patrulea studiu clinic de fazã II a Atiprimod în carcinoide avansate de pacienþi cu cancer - Callisto Pharmaceuticals Opens Fourth Site For Phase II Clinical Trial Of Atiprimod In Advanced Carcinoid Cancer Patients - articole medicale engleza - startsanatate