Despite three decades of clinical trial research involving thousands of patients with multiple myeloma and the recent approval of new drugs, the disease continues to be fatal for most patients
Searching for a cure for multiple myeloma Despite three decades of clinical trial research involving thousands of patients with multiple myeloma and the recent approval of new drugs, the disease continues to be fatal to the majority of patients. Callisto Pharmaceuticals has taken a major step toward the start of human clinical trials for Atiprimod, its drug to battle multiple myeloma, a devastating bone marrow cancer.
At the same time, Callisto announced that three prominent cancer experts have joined its scientific advisory board and board of directors, and taken the lead in coordinating the planned clinical trials. Callisto CEO Gary Jacob announced the filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for Atiprimod, a procedural requirement.
Upon FDA approval, the Phase I/IIa clinical trial will evaluate the safety and efficacy of drug treatment for patients with refractory or relapsed multiple myeloma.
The trial will take place at leading cancer hospitals in the United States, including the University of Texas MD Anderson Cancer Center, where the trial will be coordinated by leading cancer clinician and investigator, Moshe Talpaz.
Dr Talpaz, chairman of the department of bioimmunotherapy at MD Anderson, was part of the original group that developed the drug Gleevec, also known as STI571 for the treatment of a rare life-threatening form of cancer, chronic myeloid leukemia (CML).
The primary objective of the Atiprimod trial is to identify the maximum tolerated dose (MTD) and safety of Atiprimod in multiple myeloma patients.
The secondary objectives are to evaluate the response of relapsed multiple myeloma patients, measure the drug pharmacokinetics (the study of the bodily absorption, distribution, metabolism and excretion of drugs) and evaluate a wide variety of surrogate markers to better define the mechanisms of action for Atiprimod. "The filing of this IND is a significant milestone for Callisto", said Dr Jacob.
"We are very excited about the potential of Atiprimod to treat multiple myeloma patients".
Multiple myeloma is a common hematological malignancy (10% of all hematological cancers) and represents 1% of all cancer malignancies.
There are currently approximately 50,000 patients in the USA, with approximately 15,000 newly diagnosed patients yearly.
Despite three decades of clinical trial research involving thousands of patients with multiple myeloma and the recent approval of new drugs, the disease continues to be fatal to the majority of patients.
Atiprimod is a drug that has completed a Phase I/IIa clinical trial in rheumatoid arthritis patients with patient dosing as long as one year.
The drug is now entering clinical trials in multiple myeloma based on a wide range of compelling preclinical data for this particular cancer.
Atiprimod has also shown potent activity against a wide range of solid tumors in in-vitro screens and will be evaluated in animal models of solid tumors to expand Atiprimod's clinical trial indications.
Callisto has an exclusive worldwide license from Anormed to develop, manufacture, use and sell Atiprimod.
As Callisto prepares to begin the new trial, two prominent cancer experts have joined Callisto's scientific advisory board and board of directors, respectively. Kenneth Anderson, director of the Jerome Lipper Multiple Myeloma Center of the Dana-Farber Cancer Institute in Boston, MA, and Professor of Medicine at Harvard Medical School, has become a member of the scientific advisory board.
Dr Anderson's recent success was in helping to develop Velcade, which received speedy approval from the Food and Drug Administration (FDA) in May, 2003, for the treatment of multiple myeloma.
"I am happy to join the Scientific Advisory Board and excited to see Callisto's drug candidate for multiple myeloma, Atiprimod, moving forward into clinical development," he said.
Also, Michael Zelefsky, a radiation oncologist and chief of the brachytherapy service at Memorial Sloan Kettering Cancer Institute in New York, joined Callisto's board of directors. Dr Zelefsky has been the principal investigator on many clinical research studies that have included protocols incorporating novel drugs in conjunction with radiotherapy for the treatment of locally advanced cancers.
Dr Zelefsky was the principal investigator who tested C225 in conjunction with chemo-radiotherapy for advanced head and neck cancer as well as the current P1 on a Phase III randomised trial testing the role of Zoladex hormone therapy in conjunction with high-dose radiotherapy.
"I have been extremely impressed with the team at Callisto and am very excited to see Callisto's drug Atiprimod moving into human clinical trials for multiple myeloma this autumn," said Dr Zelefsky.
Dr Jacob was previously associated with Monsanto as director of glycosciences and science fellow.
