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| |  New Drug May Be Effective Treatment For MS NEW HAVEN, Conn., April 28 , 1997 -- The results of a study demonstrating the efficacy of Alexion Pharmaceuticals' proprietary Apogen compound, MP4, for the treatment of multiple sclerosis (MS) in primates were demonstrated Saturday, April 26, at the Biomedicine '97 conference, the annual meeting of the American Society for Clinical Investigation, scientists of the National Institutes of Health (NIH). In the study reported, relative to untreated control animals, treatment with MP4 reduced the severity of MS-like disease symptoms as well as prolonged the time to onset of lesions detected by magnetic resonance imaging. The findings were presented by Dr. Michael Lenardo, lead investigator of the study and a Senior Investigator in the Laboratory of Immunology of the National Institute of Allergy and Infectious Diseases. "Throughout the course of the four month study, there was a clear dose-dependent reduction in the severity of symptoms, with animals in the higher dose treatment group displaying no apparent clinical manifestations of disease," stated Dr. Lenardo. "In addition to MP4's potential efficacy, we observed no apparent toxicity associated with the treatments, thus indicating potential safety of MP4 in nonhuman primates." The study was performed in common marmosets, an outbred primate species with well characterized susceptibility to autoimmune demyclinating disease. When immunized with proteins derived from human myelin (the protective sheath that provides insulation for nerves in the brain) untreated marmosets develop a primary relapsing and remitting neurological disease characterized by significant similarities to human MS. There is substantial evidence that central nervous system damage in MS is caused by T lymphocytes that recognize myelin protein antigens in the brain. MP4 is a recombinant molecule designed to eliminate disease-causing T lymphocytes that target epitopes in myelin basic protein and proteolipid protein, the two proteins which together comprise 80% of the myelin sheath. In scientific studies previously performed at NIH, it was shown that intravenous antigen administration was able to selectively eliminate disease-causing, autoreactive T-cells in vivo. In a preclinical study published last year in the Journal of Clinical Investigation, intravenous MP4 was shown to reverse ongoing disease in another standard model of MS. "These preliminary findings represent an important extension of our ongoing studies demonstrating that parenteral (non-oral} antigen therapy can suppress manifestations of severe autoimmune disease," said Dr. Louis Matis, Vice President of Research, Immunobiology at Alexion. "We are aware of no other treatment, at this point, that has proven both safe and effective in a primate model of MS. We intend to file an IND this year to initiate clinical trials with MP4 in MS patients." MS is the most common disease-related cause of neurological disability in early to mid-adulthood, affecting more than 350,000 Americans. It is twice as common in women as in men. MS causes crippling loss of muscle control and coordination, which may lead to paralysis, and in some cases, death. In some sufferers, MS also causes loss of sensory functions and mental acuity. Alexion Pharmaceuticals was founded in 1992 and is engaged in the development of selective immunotherapeutic drugs that generally are designed to inhibit the disease-causing segments of the immune system while preserving the disease-preventing aspects of the immune system. The company is developing three technology platforms: C5 Complement Inhibitors and Apogen T-Cell Therapeutics which together target severe cardiovascular and autoimmune disorders; and xenografts for organ transplants.
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