ASH: AMD3100
AnorMED announces the first report of clinical results on MOZOBIL (AMD3100), a first in class stem cell mobilizer, from the compassionate use protocol (CUP) in cancer patients requiring a stem cell transplant. Cancer patients enrolled in the MOZOBIL CUP program failed prior attempts to collect stem cells for transplant using standard mobilization regimens. Data reported shows that remobilization with MOZOBIL and G-CSF allowed patients to collect enough stem cells for a transplant. Preliminary results on the first 70 CUP patients were released today in an oral presentation given by Dr. Joseph McGuirk, Medical Director of the Kansas City Blood and Marrow Transplant Program, at the American Society of Hematology (ASH) conference.
"Stem cell mobilization is an important but difficult process for cancer patients. Depending on the type of disease, more than 20 percent of patients just can't mobilize enough stem cells, that later will get them through the intense chemotherapy they need to survive. The strongest predictor of success in transplantation is the number of stem cells available for transplantation," said Dr. McGuirk. He added, "MOZOBIL gave the patients in the compassionate use program a fighting chance to collect enough stem cells for a potentially life-saving transplant after prior attempts using G-CSF alone or chemotherapy plus G-CSF mobilization failed."
Overall 42/70 CUP patients (60%) collected the minimum number of stem cells required to go onto transplant (2 million CD34+stem cells/kg of patient weight), without having to pool prior collections, when re-mobilized with MOZOBIL and G-CSF. The median collection for the 42 patients was 4.6 million CD34+ stem cells/kg of patient weight. Of the 42 patients, 38 were transplanted, 3 expired prior to platelet engraftment due to disease progression and 30 are now at six months post transplant or beyond.
MOZOBIL & Allogeneic Transplant
Additionally, Dr. Steven Devine, Associate Professor of Medicine, Director, Blood and Marrow Transplant Program, Ohio State University School of Medicine reported an update on a pilot study from Washington University using MOZOBIL as a single agent to mobilize stems cells in healthy donors for an allogeneic transplant. Results to date show eight of nine donors collected adequate stem cells to support an allograft. The six transplanted patients have all experienced successful engraftment and have had a median follow up period of 200 days.
Note: Certain of the statements contained in this press release contain forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. The Company does not expect to update any forward-looking statements as conditions change. Investors are referred to the discussion of the risk factors associated with the Company's business contained in the Company's Final Short Form Prospectus dated December 1, 2005 and filed with Canadian securities regulatory authorities and available on SEDAR.
Background on MOZOBIL
MOZOBIL has orphan drug status in both the U.S and the E.U. In December 2004, AnorMED completed the Special Protocol Assessment process with the U.S. FDA and agreed on the design and endpoints of two pivotal Phase III studies. These studies are ongoing in major transplant centers in the U.S. One study is enrolling 300 non-Hodgkin's lymphoma (NHL) patients and the other study 300 multiple myeloma patients. Both studies are randomized, double-blind, placebo controlled, comparative trials of MOZOBIL plus G-CSF versus placebo plus G-CSF.
MOZOBIL is an inhibitor of the CXCR4 chemokine receptor. The CXCR4 receptor is present on white blood cells and among other functions, has been shown to play a key regulatory role in the trafficking and homing of human CD34+ stem cells in the bone marrow. MOZOBIL is the first in a new class of agents which induces rapid mobilization of stem cells from the bone marrow into the peripheral blood system.
Source: www.anormed.com
"Stem cell mobilization is an important but difficult process for cancer patients. Depending on the type of disease, more than 20 percent of patients just can't mobilize enough stem cells, that later will get them through the intense chemotherapy they need to survive. The strongest predictor of success in transplantation is the number of stem cells available for transplantation," said Dr. McGuirk. He added, "MOZOBIL gave the patients in the compassionate use program a fighting chance to collect enough stem cells for a potentially life-saving transplant after prior attempts using G-CSF alone or chemotherapy plus G-CSF mobilization failed."
Overall 42/70 CUP patients (60%) collected the minimum number of stem cells required to go onto transplant (2 million CD34+stem cells/kg of patient weight), without having to pool prior collections, when re-mobilized with MOZOBIL and G-CSF. The median collection for the 42 patients was 4.6 million CD34+ stem cells/kg of patient weight. Of the 42 patients, 38 were transplanted, 3 expired prior to platelet engraftment due to disease progression and 30 are now at six months post transplant or beyond.
MOZOBIL & Allogeneic Transplant
Additionally, Dr. Steven Devine, Associate Professor of Medicine, Director, Blood and Marrow Transplant Program, Ohio State University School of Medicine reported an update on a pilot study from Washington University using MOZOBIL as a single agent to mobilize stems cells in healthy donors for an allogeneic transplant. Results to date show eight of nine donors collected adequate stem cells to support an allograft. The six transplanted patients have all experienced successful engraftment and have had a median follow up period of 200 days.
Note: Certain of the statements contained in this press release contain forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. The Company does not expect to update any forward-looking statements as conditions change. Investors are referred to the discussion of the risk factors associated with the Company's business contained in the Company's Final Short Form Prospectus dated December 1, 2005 and filed with Canadian securities regulatory authorities and available on SEDAR.
Background on MOZOBIL
MOZOBIL has orphan drug status in both the U.S and the E.U. In December 2004, AnorMED completed the Special Protocol Assessment process with the U.S. FDA and agreed on the design and endpoints of two pivotal Phase III studies. These studies are ongoing in major transplant centers in the U.S. One study is enrolling 300 non-Hodgkin's lymphoma (NHL) patients and the other study 300 multiple myeloma patients. Both studies are randomized, double-blind, placebo controlled, comparative trials of MOZOBIL plus G-CSF versus placebo plus G-CSF.
MOZOBIL is an inhibitor of the CXCR4 chemokine receptor. The CXCR4 receptor is present on white blood cells and among other functions, has been shown to play a key regulatory role in the trafficking and homing of human CD34+ stem cells in the bone marrow. MOZOBIL is the first in a new class of agents which induces rapid mobilization of stem cells from the bone marrow into the peripheral blood system.
Source: www.anormed.com
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