Genmab — Oktober 2014

[Solsen]

MIRROR: Threshold Identified for Ofatumumab Therapy in MS

Results of the phase 2 study suggest that an optimal dose can be found that will give maximal suppression of MS lesions without completely eradicating all B cells.

Medscape (www.medscape.com)

[Sukkeralf]

Uanset hvad betyder det vel ikke så meget, for det er en lille indikation og royalty i de autoimmune sygdomme er kun 10%. Men så længe Arzerra ikke omsætter for mere, så kan vi bruge al omsætning

[Solsen]

Ja skidt med den indikation....bortset synd for pts.

[Sukkeralf]

Hvad står der i dit link - har ikke adgang

[Solsen]

Presenting the new analysis at the American Academy of Neurology (AAN) 66th Annual Meeting, Daren Austin, PhD, from GSK UK, explained that the study included a large range of doses in an attempt to pinpoint the lowest dose for significantly reducing MRI lesion activity.

[Solsen]

Forstår ikke du ikke har adgang - Medscape...

[Solsen]

For the MIRROR study, 231 patients with relapsing-remitting MS were randomly assigned to 1 of 4 doses of ofatumumab or placebo. The 4 doses were 3 mg every 12 weeks, 30 mg every 12 weeks, 60 mg every 12 weeks, and 60 mg every 4 weeks. After 12 weeks, the placebo group received 3 mg of ofatumumab. The study treatments were given for 24 weeks. The primary endpoint was suppression of MRI lesion activity during the first 12 weeks.

Results suggested a 90% or greater reduction in the cumulative numbe

[Solsen]

Results suggested a 90% or greater reduction in the cumulative number of new T1 gadolinium-enhancing lesions for all cumulative doses of ofatumumab 30 mg or greater during weeks 4 to 12.

[Solsen]

Det kan jo være yderligere data og dosisforsøg har påvist at 10 mg er nok.

[Solsen]

3 mg er trods alt faktor 3 mindre end 10 mg.

[Solsen]

3 mg hver 12 uge gav 71% reduction i lesions. Ganske pænt -
dosis og frekvens taget i betragtning.

[Solsen]

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[Solsen]

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[Solsen]

Safety fra MIRROR...There were no unexpected safety findings in the study, the company reports. Between weeks 0 and 12, injection-related reactions were the most common adverse reaction, seen in 52% of patients receiving ofatumumab vs 15% of those receiving placebo. Five serious adverse events were reported, all in patients receiving the 60-mg dose, but none of these patients withdrew from the study.

[Solsen]

Kun serious adverse events i 60 mg gruppen.

[investor1989]

Som US ser ud lige nu får den nok tæsk tæsk tæsk imorgen

[Solsen]

Jo det ligner at vi går i bearmarked desværre.

[investor1989]

det lignede et sammenbrud i luk

[JSEH]

I89 hvad siger du til Protector? skal man være nervøs?

[nohope]

Men min angst maa forløses i længsel

og i syner af rædsel og nød.

Jeg har længtes mod skibskatastrofer

og mod hærværk og pludselig død