AnorMED Inc. announced the initiation of its fourth Phase II clinical trial to evaluate AMD3100 as a new stem cell transplantation drug candidate for cancer patients. Clinical data to date in cancer patients shows AMD3100 effectively 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.

This Phase II trial will be conducted at multiple centres in the United States and will enroll up to 30 non-Hodgkin’s lymphoma and multiple myeloma patients. The objective of this study is to determine if patients who are given AMD3100 plus a mobilization regimen of chemotherapy and granulocyte-colony stimulating factor (G-CSF) have more stem cells available for transplantation.

AMD3100 is a novel drug candidate, developed by AnorMED that blocks a specific cellular receptor triggering the movement of stem cells out of the bone marrow and into the circulating blood. AnorMED’s clinical programme on AMD3100 is being conducted at multiple transplant centres in the US. Data from 140 participants, from all clinical studies conducted by AnorMED on AMD3100 to date, show the drug candidate has a good safety profile.

Stem cell transplantation is a standard medical procedure used to restore the immune system of patients who have had chemotherapy to treat cancers such as multiple myeloma and non-Hodgkin’s lymphoma, among others. The strongest predictor of success in transplantation, measured by the rapid and durable recovery of a patient’s immune system, is the number of stem cells available for transplantation.

Approximately 50 per cent of transplant patients have poor or sub-optimal mobilization of stem cells from the bone marrow into the bloodstream using G-CSF. Currently, there are no medical guidelines to predict which patients will respond poorly to G-CSF mobilization. These patients may require additional mobilization and cell collection sessions to achieve a sufficient number of stem cells for transplantation. Some patients, particularly those transplanted with a sub-optimal number of cells, experience a delayed recovery of their immune system. These patients are at greater risk for infection and may require additional days of antibiotics, blood transfusions and extended hospitalization.

AMD3100, in combination with G-CSF, has shown potential to help more patients have successful transplants with less medical complications, time and associated costs. Dr Neal Flomenberg, chief, Division of Medical Oncology, Thomas Jefferson University, Philadelphia, PA and a principal investigator in AnorMED’s clinical program on AMD3100, presented results from 19 patients enrolled in a Phase II study of AMD3100 at the American Society of Hematology conference in December 2003. New clinical data from a Phase II trial of AMD3100 in multiple myeloma patients, who have previously failed stem cell mobilization, will be presented at American Society of Clinical Oncology Conference, to be held June 5-8 2004, in New Orleans.