Dendreon Corporation Broadens Trials of Mylovenge Vaccine in Multiple Myeloma; Trial to Examine Mylovenge Used in Combination With Thalidomide.Business Editors & Health/Medical Writers BIOWIRE2K SEATTLE--(BW HealthWire)--Nov. 6, 2001 Dendreon Corporation (Nasdaq:DNDN) announced today the initiation of a new Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of Mylovenge(TM), its therapeutic cancer vaccine for multiple myeloma multiple myeloma A malignant proliferation of abnormal plasma cells that populate the marrow-containing bones of the body. The affected plasma cells produce myeloma protein, a monoclonal antibody that replaces normal antibodies in the blood, thereby increasing susceptibility . The trial is designed to assess the ability of Mylovenge to stimulate immunity in patients who are currently responding to thalidomide thalidomide (thəlĭd`əmĭd'), sleep-inducing drug found to produce skeletal defects in developing fetuses. The drug was marketed in Europe, especially in West Germany and Britain, from 1957 to 1961, and was thought to be so safe that . "Thalidomide has become one of the most widely used drugs in the treatment of multiple myeloma. While patients often go into remission on the drug, they are inevitably left with minimal residual disease residual disease Oncology Malignant cells or neoplasia that remains after any form–chemotherapy, surgery, RT–of 1º treatment ," said Michael W. Schuster, M.D., Professor of Clinical Medicine at the Weill Medical College of Cornell University and Director of The Bone Marrow and Blood Stem Cell stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. Transplant Program at the New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of Presbyterian Hospital. "We believe that treatment with Mylovenge at this point might lead to greater long-term disease free survival." Patients will be enrolled in the trial at the New York Presbyterian Hospital/Weill-Cornell Medical College "We have been very pleased with initial clinical trial results from patients receiving Mylovenge either prior to or following routine stem cell transplantation Stem Cell Transplantation Definition Stem cells are basic human cells that reproduce (replicate) easily, providing a continuous source of new, sometimes different types of cells. ," said Frank Valone, M.D., senior vice president of clinical and regulatory affairs at Dendreon. "With the standard of care for the treatment of multiple myeloma evolving, we want to examine Mylovenge in this new setting. Information gathered from this trial will be helpful in positioning Mylovenge for optimal use in the treatment of patients with this cancer." Mylovenge is designed to trigger the body's immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. to recognize and destroy cancer cells. It involves isolating dendritic cells from a patient's blood and activating them with a protein, called an M component or idiotype id·i·o·type n. A determinant that confers on an immunoglobulin molecule an antigenic individuality that is analogous to the individuality of the molecule's antibody activity. , that is specific for each patient. The activated dendritic cells are infused back into the patient to stimulate an immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. . Preliminary results of two recently completed clinical trials suggest that Mylovenge treatment is safe, and that it stimulates immune activity and may cause disease regression or stabilization. In some patients, clinical benefits were found to extend more than 18 months following treatment. For more information about participating in this trial, please call the New York Presbyterian Hospital/Weill-Cornell Medical College at 212/746-2119. About Multiple Myeloma Multiple myeloma is a cancer of the blood. Plasma cells are overproduced in the bone marrow, leading to damage to normal blood cells and to bone. Multiple myeloma accounts for approximately 10% of cancers of the blood. The American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, estimated that 13,600 individuals in the U.S. would be diagnosed with multiple myeloma in 2000 and over 11,000 individuals would die from the disease. Dendreon Corporation (www.dendreon.com) is dedicated to the discovery and development of novel products for the treatment of cancer through its innovative manipulation of the immune system. Dendreon is focused on the development of therapeutic cancer vaccines through the use of antigen discovery, antigen engineering and dendritic cell technologies. Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such a difference include risks related to Dendreon's limited operating history, risks associated with completing Dendreon's clinical trials, the risk that the safety and/or efficacy results of a clinical trial will not support an application for a biologics license, the risk that the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. will not approve a product for which a biologics license has been applied, the uncertainty of Dendreon's future access to capital, the failure by Dendreon to secure and maintain relationships with collaborators, dependence on the efforts of third parties, and dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations, are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. |
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