Callisto Pharmaceuticals, Inc., a developer of new drug treatments in the fight against cancer and other major health threats, announced the official opening of its first clinical site for its phase II clinical trial of Atiprimod to treat low to intermediate grade neuroendrocrine carcinoma (advanced carcinoid cancer).
The site, Haematology Oncology Services of Arkansas in Little Rock, Arkansas, which is headed by Principle Investigator Dr. Brad Balz, specializes in the treatment of solid tumours, and is presently screening patients for entry into the trial. Further details of this trial can be found at http://www.clinicaltrials.gov. Several other major cancer centres are currently in the process of reviewing the trial protocol and the Company anticipates that they will open in the near future.
"We are very excited to have opened the Arkansas site, and are looking forward to rapidly enrolling patients. This clinical trial will enable us to build on what was observed in a small number of carcinoid patients that gave promising data in an earlier Phase I clinical study of advanced cancer patients at the M.D. Anderson Cancer Center," said Dr. Donald Picker, Callisto's Executive Vice President of Research and Development. "There is no approved effective treatment for these relapsed advanced carcinoid patients who many times also continue to have debilitating symptoms related to this disease. Any possible treatment would be a major advance for these patients."
"Providing new and safer options to treat patients with advanced cancers such as metastatic carcinoid tumours makes this an exciting time to be practicing medicine," comments Dr. Balz of Haematology Oncology Services. "Historically, I have only been able to offer symptom management to carcinoid patients. This clinical trial of Atiprimod will offer new hope for treatment of patients with this debilitating cancer."
Atiprimod is an orally bio-available small molecule drug that displays multiple mechanisms of action. The drug is presently in 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 tumours and symptoms that were no longer controlled by the standard therapies utilized. During treatment, three of the five advanced carcinoid patients had measurable tumour regressions and loss of many of the debilitating symptoms of this disease.