"Advanced carcinoid tumors have proven to be very difficult to treat effectively, and accordingly there are very few options available that offer hope to patients with these late-stage tumors," notes Dr. Gary S. Jacob, Chief Executive Officer of Callisto. "The basis for moving forward with this Phase II trial with Atiprimod comes from encouraging data observed in patients with advanced carcinoid tumors enrolled in an earlier Phase I/IIa clinical trial of Atiprimod in advanced cancer."
"An important component of this Atiprimod Phase II trial is the evaluation of not only tumor regression but improvement of the debilitating symptoms typically associated with this neuroendocrine cancer," said Robert C. Shepard, M.D. F.A.C.P., Callisto's Chief Medical Officer. "Patients will be keeping daily diaries to monitor their symptoms. The earlier Atiprimod Phase I/IIa trial with advanced carcinoid patients suggested that this drug has the potential of improving symptom management as well as shrinking tumors."
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 three clinical trials: a Phase II trial in advanced carcinoid cancer patients, a Phase I/IIa human clinical trial in relapsed or refractory multiple myeloma patients, and in a Phase I/IIa trial in advanced cancer patients. Callisto earlier announced in June, 2006 interim data from the 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.
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.
