IDM Announces Launching a Phase II Clinical Trial With Uvidem, its Therapeutique Vaccine for the Treatment of Melanoma.Business Editors, Health/Medical Writers PARIS--(BUSINESS WIRE)--Nov. 4, 2002 IDM (1) See identity management. (2) (Integrated Device Manufacturer) A company that performs every step of the chip-making process, including design, manufacture, test and packaging. Examples of IDMs are Intel, AMD, Motorola, IBM, TI and Lucent. Immuno-Designed Molecules, a European biopharmaceutical company specializing in cellular immunotherapy, announces the launch of the Phase II trial of its therapeutic vaccine therapeutic vaccine Immunology A vaccine–eg, Salk's Remune™ intended to treat a viral infection by stimulating the immune system. See Vaccine therapy. Uvidem(TM) (IDD-3) for the treatment of melanoma. The trial is open to patients with metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. melanoma who have received no more than one chemotherapy line and whose lesions can be accurately measured. A total of 60 patients will be recruited at ten centres in France, Germany and Australia. The trial is being coordinated by Dr. Isabelle Gorin, Department of Dermatology at the Hopital Tarnier-Cochin Hospital in Paris. Uvidem is the result of research conducted at IDM and has been developed in collaboration with the Sanofi-Synthelabo pharmaceutical company. Uvidem is a Cell Drug containing dendritic cells which have been generated using IDM's patented technology in presence of Interleukin interleukin Any of a class of naturally occurring proteins important in regulation of lymphocyte function. Several known types are recognized as crucial constituents of the body's immune system (see immunity). 13. Dendritic cells are prepared from the patient's own leukocytes (specifically, the monocyte monocyte /mono·cyte/ (mon´o-sit) a mononuclear, phagocytic leukocyte, 13µ to 25µ in diameter, with an ovoid or kidney-shaped nucleus, and azurophilic cytoplasmic granules. fraction) together with an antigen specific for the target cancer cells. The Cell Drug generated by IDM is subsequently injected back into the patient in order to stimulate the 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. against the patient's cancer. The study population will be randomly divided into two groups, one of which will be treated with a Cell Drug containing normal dendritic cells and the other with "matured" dendritic cells. This will make it possible to determine whether maturation of the cells is associated with improving the immune response. Patients will be treated for twenty weeks and followed up for one year. The aim of the trial is to assess the safety of the treatment, the immune response, and the clinical outcome. The safety of this type of product has already been investigated in a Phase I trial conducted in 15 patients, in which no serious adverse events associated with the treatment were reported. At this time, melanoma is the form of cancer with the most rapidly increasing incidence: in 2001, 52,000 new cases were recorded in the United States, and 7,000 in France. The mortality rate is 15%. Excessive exposure to ultraviolet radiation is the major risk factor. IDM - The Immunogenics Company(R) IDM is a leading biopharmaceutical company developing a new family of immunotherapy products called Cell Drugs to fight cancer and other life-threatening diseases. IDM applies its proprietary technologies to selectively isolate, engineer, expand and activate specific cell populations which are involved in therapeutic vaccination. The Company's products are designed to boost the 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. , destroy residual tumor cells, and immunize im·mu·nize v. 1. To render immune. 2. To produce immunity in, as by inoculation. im patients to prevent tumor recurrence. IDM's most advanced product is in Phase III for the treatment of ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast . For more information, please visit IDM's Web site, http://www.idm-biotech.com
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