AnorMED expands stem cell transplant program in cancer patients to include Canada and the European Union
AnorMED Inc. announced the initiation of Phase II clinical trials in Canada and the European Union to evaluate AMD3100 as a new stem cell transplantation drug candidate for cancer patients. Clinical data to date in cancer patients shows AMD3100 increases the number of stem cells available for transplantation. The strongest predictor of success in stem cell transplant is the number of stem cells available for transplantation.
"New agents that could potentially improve the stem cell transplant procedure and outcomes are important, as the success of transplants is critical in the treatment of many cancer patients. We are particularly pleased to work with AMD3100 and are encouraged by the clinical data published to date," said Armand Keating, Professor and Head, Department of Medical Oncology and Hematology at Princess Margaret Hospital.
The Canadian trial sites will include Princess Margaret Hospital in Toronto and the Vancouver General Hospital. In Europe, studies will be initiated at the University of Heidelberg in Germany and the University Hospital Carl Gustav in Dresden. Both the Canadian and European Phase II trials will be conducted at multiple centers and will enroll up to a total of 50 non-Hodgkin's lymphoma and multiple myeloma patients. AMD3100 will be used in combination with the standard agent, granulocyte-colony stimulating factor (G-CSF), to mobilize stem cells from the bone marrow into the bloodstream where they can be collected and used for transplantation.
AMD3100 is a stem cell mobilizer. When used in combination, AMD3100 and G-CSF work together to generate an increase in the number of stem cells in the bloodstream. In this capacity, AMD3100 may increase the stem cells available for collection as well as improve the transplantation procedure by reducing the number of times cells would have to be collected.
AnorMED has filed a special protocol assessment with the FDA for its Phase III protocols, and contingent on a positive response, plans to initiate these studies early in 2005. The company is also conducting an ongoing Phase II program in transplant to evaluate AMD3100 in combination with different stem cell mobilizing regimens including chemotherapy, as well as in cancer patients with Hodgkin's disease. Currently, an investigator sponsored study is ongoing to evaluate AMD3100 as a single agent in allogeneic transplant.
Approximately 45,000 stem cell transplantations are performed yearly worldwide. Bone marrow transplants, where stem cells are collected from patients using an invasive procedure, are now being replaced by peripheral blood stem cell transplant. In this procedure, stem cells are collected from the circulating blood for transplantation. Prior to collection, patients are given G-CSF which causes stem cells in the body to multiply. The objective of this procedure is to get as many stem cells as possible into the circulating blood where they can be collected.
AMD3100 was developed by AnorMED and has been granted Orphan Drug status by both the FDA and the European Commission.
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