ECTRIMSSept 2009
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`The European Committee for Treatment and Research in MS held their annual
`meeting from September 9-12. Here are same of the presentations that I
`found interesting.
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`It reduced relapse rate by
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`Treatment
`There were reports on a number ofclinicaltrials, mainly of oral agents which are summarized below.
`Fingolimod: Furtherresults from the TRANSFORMSstudy were reported. Theinitial results were
`feLUSie aaee
`reported at AAN earlier this year. This was a large study with over 400 patients per arm, and
`fingolimod was comparedto interferon rather than using a placebo control. The effectiveness looks
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`good with over a 50% reduction in relapse rate. Safety is a concem, since there were 2 fatal virus
`infectionsin the treatment group.
`au
`Deeneeees
`@, Oral ciadribine,furtherresults from the CLARITY study. Again, theinitial results of this study
`7 September, 2018
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`ee were reported at the AAN, and it was a large study with over 400 patients in each group,
`with cladribine compared to placebo. The relapse rate was reduced 58%, and MRIactivity
`i ay EE
`decreased 88%. No safety concerns were identified, but they remain a concern with a cytotoxic
`drug like this.
`teseeseunere
`¢ BG12 or fumarate: This agentis earlierin the clinical trial process.
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`about 30% compared to placebo,
`Laquinimod: they reported safety results which look promising.
`meeecits eyee
`TeoMEL
`& Teriflunomide: This is another oral agent with immunomodulatory effects, This was a phaseII
`study with around 40 patients per arm, and the drug was used as an add-onto interferon. MRI
`TOL kUraoe
`activity decreased by about 80%.
`Mere: Ba)|
`Atorvasiatin in early MS: this is a cholesterol towering drug, which mayalso be useful in MS.
`eSSTs)
`By They didn’t enroll as many patients as they planned with only 82 tofal patients, and there wasn't any
`m obvious benefit,
`Dirucotide: This is a peptide from myelin basic protein, and it was used in a study with over 500
`me secondary pragressive MS patients. There was no benefit.
`in summary, there are a numberoforal treatments in development, some of which may be more
`iNTeiUEeelsatendaeeyadc) i.
`effective than our current standard treatments. The combination of increased effectiveness and
`safety is elusive, The single trial in progressive MS was negative, butit is good to see treatments
`eee being tried in progressive disease since the majority of drugs are for relapsing MS.
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`Giatiramer--update 11/07
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`| heard several presentations of some fresh ideas. One of the keynote lectures was given by Dr.
`; : Prineas, a pathologist, who has somedifferent ideas on the cause of MS. Most researchers focus on
`the role of autoimmunity in damaging myelin and oligodendrocytes. Dr. Prineas suggested that the
`= primary problem in MSis that oligodendrocytes die off first, and then the immunecells comein to
`clean up ihe myelin debris. He thinks the primary problem may be with the astrocytes, one of the
`cells in the brain that provides support to the othercells. ['m not sure he has a convincing story yet,
`@ Dut he definitely has interesting ideas and a different approach.
`# Dr. Derfuss from Dr. Meinl's group gave an excellent talk on the proteins neurofascin and contactin
`as possible targets of the autoimmuneaitack in MS. These are relatively minor proteins, but they
`are located at the junction where the myelin binds to the axon, These proteins werefirst identified
`a) by finding myelin proteins that were recognized by antibodies from MS patients, and they have gone
`& on to do experimental work te demonstrate that immune attack on these proteins can cause
`@ demyelination. We definitely need to think beyond myelin basic protein and proteolipid protein as
`the targets of immuneatiack, and | think this is a step in the right direction,
`Epstein-Barr virus continues to be controversial. Some investigators san find it in the brain, and
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`3 others cannot.Jthink it will be a while before that issueis settled. ppm
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`iitpvAviwwjwlindseymd.convid69.hinl
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`9116/2019
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`Biogen Exhibit 2228
`Mylanv. Biogen
`IPR 2018-01403
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`Page 1 of 2
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`Biogen Exhibit 2228
`Mylan v. Biogen
`IPR 2018-01403
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`

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`ECTRIMS Sept 2009
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`J. Willlam Lindsey, MD
`University of Texas Multiple Sclerosis Research Graup
`Housfon, Texas
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`copyright 2007-2020 John Willlam Lindsey
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`httpv/woww,jwlindseymd.conr/id69.himlt
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`9/16/2019
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