AnorMED announced the initiation of a Phase II clinical trial to evaluate the potential of AMD-3100 as a new agent for stem cell transplantation in cancer patients. In this study, AMD-3100 will be given in combination with the standard agent, G-CSF or Neupogen, to patients with multiple myeloma and non-Hodgkin's lymphoma (NHL).
Stem cell transplantation involves the collection of certain types of stem cells that are used to restore the immune system of patients following their radiation and/or chemotherapy treatments for cancers involving the blood and immune system such as leukemias, multiple myeloma and lymphomas.
"The ability to collect as many stem cells as possible from the patient prior to their cancer treatment can greatly improve the chances that their immune system can be restored. We believe AMD-3100 has a potential role to play in improving the treatment of these patients," said Dr. Gary Calandra, VP Clinical Development at AnorMED. He added, "This trial is part of the Company's clinical program to evaluate the ability of AMD-3100 to increase the stem cells available for transplant, improve the overall transplantation procedure, and potentially enhance patient outcome."
This Phase II trial will be conducted at multiple centers in the United States and will enroll up to 24 cancer patients with either multiple myeloma or non-Hodgkin's lymphoma. The objective of this study is to determine if patients who are given AMD-3100 plus G-CSF, compared to G-CSF alone, have more stem cells available for transplantation. This study will also evaluate the number of apheresis collections needed to obtain the target number of stem cells required for transplantation. In addition, this study will evaluate the number of days it takes for stem cells to re-engraft in patients who are mobilized with AMD-3100 plus G-CSF compared to G-CSF alone.
AMD-3100 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 circulating blood. A number of Phase I studies in healthy volunteers demonstrate that a single injection of AMD-3100 increases the number of stem cells up to 15 times normal, in the circulating (peripheral) blood. Peak stem cell increases were observed six hours after injection and subsequently returned to normal levels. In addition, clinical data show that the combined use of AMD-3100 and Neupogen act synergistically, generating more stem cells than either agent alone. Also, data to date confirm that stem cells mobilized by AMD-3100 alone from healthy volunteers can be successfully transplanted in preclinical models.