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PRNewswire - November 7, 2001
"These new results are very encouraging and consistent with data from our previous clinical and preclinical studies. On the basis of this data, we plan to continue with a clinical development program. This includes the initiation of a second Phase I trial to evaluate synergies between AMD-3100 in combination with the standard agent used in stem cell transplantation in the early new year and a Phase II trial to follow the second half of next year. In conjunction with our recent publication demonstrating the anti-inflammatory activity of a CXCR4 inhibitor in a rheumatoid arthritis model, this new data reinforces our commitment to building our Chemokine Inhibitor program", said Dr. Michael J. Abrams, President and CEO of AnorMED. "We look forward to the presentation of this data at the upcoming ASH meeting and continue to believe that inhibitors of the CXCR4 and other chemokine receptors have potential as novel therapeutics in a wide variety of indications including inflammation, cancer and HIV", added Abrams.
Approximately 50,000 stem cell transplantations are performed yearly worldwide. Transplantation involves the collection of certain types of stem cells, specifically CD34+ cells, prior to radio- and/or chemotherapy. These cells are then re-administered to the patient in order to re-establish the immune system. Currently, stem cells are collected from the blood for transplantation following administration of a stimulating factor called G-CSF (granulocyte colony stimulating factor) to the patient or a stem cell donor. AMD-3100 may potentially be used in a similar capacity to enhance the stem cells available for harvesting as well as improve the transplantation procedure by reducing the number of times cells would have to be harvested.
AMD-3100 is an inhibitor of the CXCR4 chemokine receptor. Chemokines are proteins produced in the body that regulate the development and migration of various cell types, such as white blood cells, and are potentially involved in a variety of disease indications including inflammation, cancer and HIV infection. Chemokine receptors are specialized proteins that function at the surface of cells, and enable chemokines to trigger internal cellular processes. Chemokine inhibitors or antagonists block chemokine receptors, and can prevent these processes from occurring. The CXCR4 receptor is present on white blood cells and has been shown to play a key regulatory role in the trafficking and homing of human CD34+ cells in the bone marrow. In addition, a preclinical study of AMD-3100 in conjunction with the standard drug used in stem cell transplant, G-CSF, demonstrated a synergistic mobilization of hematopoietic progenitor cells. Details of these studies will be presented at the American Society of Hematology (ASH) Meeting to be held December 7-11th, 2001 in Orlando, Florida. Abstracts are now available online at http://www.hematology.org and will also be published mid-November in a special issue of Blood.
The Phase I study of AMD-3100 in the mobilization of white blood cells was performed in 10 healthy volunteers who received a single subcutaneous injection of 80 micrograms/kilogram of AMD-3100. Peak increases in numbers of stem cells were observed at six hours following injection of AMD-3100. These numbers returned to baseline within 24 hours. This study was conducted at the University of Washington in Seattle. Previously, AnorMED had studied AMD-3100 in HIV patients at continuous intravenous doses of up to 160 micrograms/kilogram/hour for 10 days. Although anti-HIV activity was observed it is believed that the continuous exposure to AMD-3100 at higher doses may have led to unexpected cardiac arrhythmia. At the doses administered in the Phase I mobilization study AMD-3100 was shown to be safe and well-tolerated in these patients. Additional details of this study are available in the abstracts and will be presented at the upcoming ASH meeting.
AnorMED is focused on the discovery and development of small molecule therapeutics for the treatment of diseases including inflammation, cancer and HIV. Within the Company's chemokine inhibitor program, the most advanced drug candidate is AMD-3100, an inhibitor of the CXCR4 chemokine receptor. It is currently in an ongoing Phase I trial to study the mobilization stem cells supporting its potential use in stem cell transplantation. The Company is evaluating a number of other compounds in this program that inhibit CXCR4 and CCR5, among others, for application in inflammation, HIV and cancer. AnorMED has a number of ongoing collaborations within its chemokine inhibitor program including the Rega Institute in Belgium, University of Copenhagen, University of Michigan, Indiana University at Indianapolis and the Institute of Cancer Research in Sutton UK. AnorMED's late stage clinical products include Foznol, which is exclusively licensed to Shire Pharmaceuticals plc. Foznol has been filed for market approval in Europe for the treatment of excess phosphate levels associated with kidney failure. Phase III trials for Foznol are ongoing in the U.S. ZD0473, exclusively licensed to AstraZeneca plc, is a new platinum based anti-cancer agent. It is currently being studied in Phase I and Phase II trials in a variety of indications. AstraZeneca are currently evaluating the Phase III development program options in ovarian cancer and other tumors. The Company also has early stage product candidates in development, and an active out-licensing and in-licensing program. AnorMED continues to build upon its drug discovery and clinical development capabilities to support the rapid advancement of its most promising therapeutic candidates into clinical trials and to attract corporate partners.
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 17, 2001.
SOURCE AnorMED Inc.
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