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AMD3100, G-CSF Combination Is a Superior Stem Cell Mobilization Regimen Than G-CSF Alone
VANCOUVER, Dec. 7 /PRNewswire-FirstCall/ -- AnorMED Inc. (TSX:AOM) announced today that AMD3100, its lead drug candidate for stem cell transplantation, helps cancer patients who would otherwise be unable to undergo a stem cell transplant because they cannot generate an adequate number of stem cells required for the procedure. These patients are referred to as poor mobilizers.
"Our Phase II results showed that 7 out of 19 cancer patients did not reach the target number of stem cells for transplantation when the standard agent, G-CSF, was used alone to collect their cells. We are very pleased to report that when AMD3100 was used in combination with G-CSF all 19 cancer patients achieved the target number for transplantation", said Dr. Gary Calandra, VP Clinical Development at AnorMED Inc.
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 Phase II data on 19 cancer patients at the American Society of Hematology conference held this week in San Diego.
"AMD3100 holds promise to cut down the number of stem cell collections patients need. The drug combination may both increase the number and improve the quality of cells collected. The greater the number of available stem cells, the more likely transplantation will be successful. In some cases, this can mean the difference between a patient being able to receive a transplant or not. The drug has little toxicity. I have a lot of hope that this drug will become a standard," said Dr. Flomenberg.
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-Hodgkins 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% 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 (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 greater risk for infection and may require additional days of antibiotics, blood transfusions and extended hospitalization.
This Phase II trial is being 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 AMD3100 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 AMD3100 plus G-CSF compared to G-CSF alone. AnorMED expects this study to be completed in Q1 2004.
Based on this study AMD3100 in combination with G-CSF is a superior stem cell mobilization regimen compared to G-CSF alone based on its ability to successfully mobilize patients who failed in the G-CSF arm, the reduction in aphereses days, and the yield of stem cells collected per day of apheresis.
Results from the study show all 19 patients mobilized with a regimen of G- CSF plus AMD3100 collected enough cells for transplantation compared to 12 out of 19 of the same patients receiving a mobilization regimen of G-CSF alone. Fourteen of nineteen 14/19 patients (74%) achieved the optimal number of cells (5 x 10(6) /Kg) with G-CSF plus AMD3100 mobilization compared to 6/19 (32%) receiving G-CSF alone.
A "poor mobilizer" is defined as a patient who fails to collect the minimum number of cells required for transplantation (2 x 10(6)/Kg) using a mobilization regimen of G-CSF alone. AMD3100 plus G-CSF helped seven poor mobilizer patients to collect a transplantable number of cells. In addition, 3 patients classified as poor mobilizers collected the optimal number of cells when mobilized with AMD3100 plus G-CSF.
As well, using the G-CSF plus AMD3100 mobilization regimen, more patients achieved the optimal number of cells (5 x 10(6)/Kg) or the minimum number of cells (2 x 10(6)/Kg) within two aphereses than the same group of patients receiving G-CSF alone. Also in the AMD3100 plus G-CSF arm 17 out of 19 patients collected a transplantable number of cells in 2 aphereses compared to 12 out of 19 in the G-CSF arm alone.
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. Data from 140 participants, from all clinical studies conducted by AnorMED on AMD3100 to date, show the drug candidate has a good safety profile and is an effective stem cell mobilizer. AnorMED's stem cell transplant clinical program on AMD3100 is being conducted at multiple transplant centers in the US.
AnorMED also plans to initiate a clinical program for AMD3100 as a potential stem cell agent to help repair damaged heart tissue in patients who have had a heart attack. The Company recently reported preclinical data at the 2003 American Heart Association Conference demonstrating that AMD3100 improves heart tissue and function when administered following a heart attack. This clinical program will begin in 2004.
AnorMED's core strength involves the application of chemistry, biochemistry and biology to the discovery and development of small molecule therapeutics for the treatment of diseases including HIV, rheumatoid arthritis, asthma and cancer. The Company has four clinical products in development and a research program focused on a novel class of compounds that target specific chemokine receptors known to be involved in a variety of diseases. Additional information on AnorMED Inc is available on the Company's website http://www.anormed.com/.
TELECONFERENCE CALL NOTIFICATION: December 8, 2003 7:00am PST/10:00am EST
On December 8, 2003 AnorMED Inc. will host a teleconference call at 7:00am PST (10:00am EST). To participate in the teleconference please dial 1- 800-640-7112 in North America or 1-416-641-6701 Internationally. This call will be taped, available two hours after the teleconference, and on replay until January 7, 2004. To hear a complete replay, please call 1-800-558-5253. The reservation number required for access is 21169763. This call will also be webcast from AnorMED's website at 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 forward-looking statements continually as conditions change. Investors are referred to the full discussion of risk factors associated with the Company's business contained in the Company's Annual Information Form filed with securities regulatory authorities dated August 18, 2003.
Notes to Editors and Reporters: Background on Stem Cell Transplant
Approximately 45,000 stem cell transplantations are performed yearly worldwide. Stem cells used to be collected from patients using an invasive procedure called bone marrow transplant. This technique is now being replaced by a new 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 such as Filgrastim (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. AMD3100 has been shown to mobilize stem cells, causing them to move out of the bone marrow and into the circulating blood. 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 effectively increases the stem cells available for collection and can also improve the transplantation procedure by reducing the number of times cells would have to be collected.
Background on AMD3100
AMD3100 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.
Source: AnorMED Inc.