Research collaborators have successfully demonstrated that use of theAnergiX compound, in in vitro studies, selectively inhibits anddestroys human immune cells in patients suffering from myastheniagravis (MG), Anergen Inc. said Wednesday.Researchers at the Neuroscience Group, Institute of MolecularMedicine, University of Oxford, England, used Anergen's proprietaryAnergiX compound for the study and results were published in theJournal of Clinical Investigation, released Wednesday.MG is an autoimmune neuromuscular disorder characterized by muscleweakness which, in severe cases, can lead to death. An estimated100,000 people worldwide are afflicted with the disease, half of themin the U.S., the Redwood City, Calif., company said."We are producing clinical material at this time and look to begin ourdefinitive toxicology studies in the near future, followed by the filingof an IND (investigational new drug application)," John Fara, presidentand chief executive officer of Anergen, told BioWorld.Researchers showed that in T-cell dependent, antibody-mediateddiseases such as MG, functional inactivation or tolerance of disease-specific T cells is possible. In the study, T cell clones generated fromMG patients were inactivated by MG/AnergiX (complexes of majorhistocompatibility complex class II and a peptide epitope fromacetylcholine receptor).The MG/AnergiX selectively induced a state of anergy in the T cells. Inaddition to inducing long-lasting tolerance in vitro, MG/AnergiXinitiated apoptosis or programmed cell death in the cells, researchshowed.In August 1993, Anergen aligned with Novo Nordisk A/S of Denmarkto develop, in addition to MG/AnergiX, therapies for multiple sclerosis(MS) and Type I diabetes.Fara said that, until now, MG and MS have been on parallel-trackprograms. But the company is considering moving MS research to afaster track."Our thinking is, we'd file an IND for MS/AnergiX late in the thirdquarter or early in the fourth quarter (of this year), followed somemonths later with an IND for MG/AnergiX," Fara said. Developmentfor the diabetes indication is in early research.Novo Nordisk, under the agreement, made an equity investment and isproviding funding that together total about $25 million over threeyears. Anergen will co-promote, in North America, products developedtogether for the treatment of MS and MG. Novo Nordisk will marketthe products, as well as diabetes products, worldwide under a royaltybearing license agreement with Anergen.

-- Jim Shrine

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