AutoImmune Inc. announced that it has begun Phase III trials of itsleading product, Myloral, in 500 patients with multiple sclerosis (MS).The trials will take place at 13 medical centers in the U.S. and Canadaover a two-year period.In the Phase I/II trial, which involved 30 patients withrelapsing/remitting MS, six of the 15 patients in the treated group hadattacks, compared with 12 of 15 patients in the control group. Furtheranalysis of the results showed that none of the males and none of theDR2-negative subjects had an attack while taking Myloral.The Phase III trials have been designed to explore the possibleconnections suggested by the earlier trials between gender and geneticfactors and response to treatment. Subjects in the Phase III trial will bedivided into four groups: male/female DR2-positive and male/femaleDR2-negative, according to Thomas Hennessey, Jr., vice president ofAutoImmune (NASDAQ:AIMM), which is located in Lexington,Mass. Clinical observations will be supplemented with data from MRIscans."We will be investigating whether different tissue types responddifferently to different treatments," Hennessey said. "In our animalstudies, using myelin basic protein derived from guinea pigs, we foundthat guinea pigs responded better than pigs and mice to the sametreatment."Myloral is an oral formulation of bovine myelin. Hennessey said thecompany's ultimate goal is to develop a recombinant human form ofmyelin basic protein.AutoImmune's treatment is based on oral tolerance therapy, a methodfor suppressing the immune system in the specific tissue where anautoimmune attack occurs that has application to diseases other thanMS. The therapy is based on the ingestion of defined quantities ofproteins derived from the organ under attack; the proteins used in theMS treatment are derived from the brain. The process results in theproduction of regulatory T cells that bind to the original antigenicprotein and release anti-inflammatory cytokines. These naturalimmunosuppressants subdue the attack on the target organ withoutaffecting the rest of the immune system.Hennessey said AutoImmune has been talking to a number of potentialpartners, although he added that the company does not need one toproceed with the trial.In addition to the MS trial, AutoImmune also has a treatment foruveitis in a Phase II trial, a form of recombinant human insulin forType I diabetes in Phase I trials, and a dosage trial under way for itscollagen-based therapy for rheumatoid arthritis.
-- Philippa Maister
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