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| |  ISICR: Multikine Demonstrates Strong Clinical Responses in Human Immunodeficiency Virus-Infected Women With Human Papilloma Virus-Induced Cervical Dysplasia VIENNA, VA -- October 9, 2001 -- The Institute of Human Virology (IHV) at the University of Maryland, Baltimore and CEL-SCI Corporation announced today the presentation of new clinical data for CEL-SCI's immunotherapy drug, Multikine™, at the Annual Meeting of the International Society for Interferon and Cytokine Research in Cleveland, Ohio. These findings could lead to a new treatment for human immunodeficiency virus (HIV)-infected women with human papilloma virus (HPV)-induced cervical dysplasia, the precursor to cervical cancer. In the U.S. alone, about 120,000 to 140,000 women have this disease and are in need of effective therapy. At the conference it was reported that all five patients treated thus far at the lowest dose in an ongoing dose-escalating study showed clinical improvement by colposcopic (stereoscopic, binocular magnification of the cervix under a focused beam of light) examination. Three out of four patients had no evidence of dysplasia on biopsy seven to eight weeks after the final injection. Biopsies on the remaining volunteer showed no apparent changes in her dysplasia. One patient was lost to follow-up. All of the patients tolerated the injections well and without any associated, serious adverse reactions. Enrollment at this dose level is completed. The evaluation of Multikine at a higher dose is ongoing as a preliminary to the initiation of a pivotal clinical trial in 2002. The presentation is entitled, "Immunotherapy with Leukocyte Interleukin, Injection for Human Papilloma Virus (HPV) Induced Cervical Dysplasia in HIV Patients," and was authored by G. Taylor, L. Ely, C. Davis, O. Ioffe, E. Talor, N. Khanna, R. Redfield, and E. Tramont at the Institute of Human Virology, the University of Maryland, CEL-SCI Corporation and the National Institute of Allergy and Infectious Diseases (NIAID). This study was supported in part by a MIPS (Maryland Industrial Partnership) grant from the State of Maryland, a program designed to foster cooperation between researchers/clinicians and industry. Human papilloma virus infection is also a leading health problem in non-HIV-infected American college age women. A large concern among women who have HPV-induced cervical dysplasia is that the surgical procedures required to treat cervical dysplasia have a high morbidity rate ranging from cervical incompetence to hysterectomy and the inability to bear children. Furthermore, cervical cancer is the second leading cause of cancer death in women worldwide. Geert Kersten, Chief Executive Officer of CEL-SCI said, "The results we have seen in this study have literally catapulted this disease to the forefront of our development work. The reasons for this are as follows: (1) We are seeing a high response rate in this very difficult to treat group of patients. (2) The drug was well tolerated and the results were achieved without any associated serious adverse reactions related to Multikine. Given the fragile health of these HIV-infected women and past experiences with other drugs in this patient population, this is very important. (3) There is no effective therapy for these HIV/HPV co-infected women and we know of no other therapies currently in clinical development for this patient population. (4) There are an estimated 120,000 to 140,000 HIV/HPV co-infected women in the U.S. alone whose needs are not adequately addressed. Co-infection with HPV is common in HIV-infected women and cervical cancer, which follows cervical dysplasia, is classified as an AIDS-defining illness. (5) We believe that HPV-induced cervical dysplasia patients who are also HIV-infected, and therefore are the most difficult to treat and cure, may represent the fastest way to bring our drug Multikine to the market." Multikine is a mixture of immune system regulators known as cytokines and chemokines at near physiologic doses. One of the cytokines, Interleukin-2, is widely used to treat cancer. Multikine has been tested in more than 150 cancer patients and in 14 AIDS patients, to date, with only minimal side effects. SOURCE: CEL-SCI Corporation Related Link: CEL-SCI Corporation.
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