MOZOBIL(TM) abstracts accepted for presentation at the American Society of Hematology Conference
15 November 2005 - 10:50PM
PR Newswire (US)
VANCOUVER, Nov. 15 /PRNewswire-FirstCall/ -- AnorMED Inc.
(AMEX:AOM; TSX:AOM) announced today that 12 clinical and
preclinical abstracts on MOZOBIL (AMD3100), a first in class stem
cell mobilizer, have been accepted for presentation at the American
Society of Hematology (ASH) annual meeting, being held in Atlanta,
Georgia, December 10-13th, 2005. Data to be reported continues to
support the potential of MOZOBIL as a new standard in stem cell
mobilization for cancer patients undergoing transplantation. In
addition, early data supports further evaluation of MOZOBIL in new
oncology applications. 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 transplant. Results to be presented at ASH include:
clinical results from AnorMED's program for the Compassionate Use
of MOZOBIL; data from a Phase II study in Hodgkin's disease
patients; and data from investigator sponsored allogeneic trials.
In addition, new clinical data from a Phase II study shows that
MOZOBIL may improve the Absolute Lymphocyte Count at day 15 (ALC15)
in autologous transplant patients. The ALC15 after autologous stem
cell transplantation is an independent, prognostic indicator for
survival in multiple hematological malignancies (Leukemia and
Lymphoma. 2005, 46: 1287- 94). Data reported in this abstract
demonstrates that the increased lymphocyte content of a MOZOBIL +
G-CSF graft may have a positive impact on transplant patient
clinical outcomes, such as relapse rate. New preclinical data also
shows that MOZOBIL disrupts the interaction of leukemia cells with
the bone marrow and may make them more sensitive to chemotherapy.
Based on this early data, AnorMED plans to initiate a clinical
study to evaluate the potential of MOZOBIL as a chemosensitizer in
leukemia patients. All MOZOBIL abstracts are available on the ASH
website at http://www.hematology.org/. AnorMED is currently
evaluating MOZOBIL in two Phase III studies ongoing in the U.S. The
Company plans to complete Phase III recruitment and three month
follow up by the end of calendar 2006. In addition, AnorMED has a
Phase II program for MOZOBIL that is ongoing in transplant centers
in the U.S., Canada and the European Union. Investigator sponsored
studies to evaluate MOZOBIL as a single agent in allogeneic
transplantation are ongoing. To date, MOZOBIL has been administered
to over 420 patients, and data from over 190 subjects and cancer
patients has been presented to date. AnorMED is a chemistry-based
biopharmaceutical company focused on the discovery, development and
commercialization of new therapeutic products in the areas of
hematology, HIV and oncology. Information on AnorMED Inc. is
available on the Company's website: http://www.anormed.com/. 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 risks factors associated with the
Company's business contained in the Company's Annual Information
Form filed with securities regulatory authorities dated June 23,
2005. For further information: Elisabeth Whiting, M.Sc. Kim Nelson,
Ph.D. VP Corporate Development & Communications Manager,
Investor Relations Tel: 604-532-4667 Tel: 604-532-4654 Cell:
604-763-4682 Cell: 604-614-2886 E-mail: Email: Notes to Editors and
Reporters: Background on Stem Cell Transplantation Stem cell
transplantation is a standard medical procedure used to restore the
immune system of patients who have had chemotherapy to treat
cancers of the immune system, such as multiple myeloma and
non-Hodgkin's lymphoma, among others. In the past, stem cells were
collected from patients using an invasive procedure called bone
marrow transplant. This technique has now been largely replaced by
a procedure called peripheral blood stem cell transplant (PBSCT).
In this procedure, stem cells are collected from the circulating
blood for transplantation. Prior to collection, patients are given
a growth factor (G-CSF - granulocyte colony stimulating factor)
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. 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. MOZOBIL has been shown to
mobilize stem cells, causing them to move out of the bone marrow
and into the circulating blood. Approximately 45,000 stem cell
transplantations are performed yearly worldwide (IBMTR/ABMTR 2003).
Up to 65% of transplant patients have poor or sub-optimal
mobilization of stem cells from the bone marrow into the
bloodstream using standard mobilization regimens, such as G-CSF
(CIBMTR data 1998-2002). 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, called apheresis, 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 a greater risk for infection and may require
additional days of antibiotics, blood transfusions and extended
hospitalization. Background on MOZOBIL 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. 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 (MM) patients.
Both studies are randomized, double-blind, placebo controlled,
comparative trials of MOZOBIL plus G-CSF versus placebo plus G-CSF.
DATASOURCE: AnorMED Inc. CONTACT: Elisabeth Whiting, M.Sc., VP
Corporate Development & Communications, Tel: (604) 532-4667,
Cell: (604) 763-4682, E-mail: ; Kim Nelson, Ph.D., Manager,
Investor Relations, Tel: (604) 532-4654, Cell: (604) 614-2886,
Email:
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