`06 July 2006
`
`Attendees:
`
`AGENDA ITEMS
`I.
`Discussion of Comments to the Protocol Drafts:
`o 109M:S301 - Double-blind, monotherapy
`o 109MS302 - 3-Arm reference comparator
`
`I. Discussion of Comments to Protocol Drafts
`• The team agreed to discuss comments to the 109MS301 (301) Study as any
`changes to this protocol will most likely need to be carried over to the 109MS302
`
`Page 1 of3
`
`Biogeo Exhibit 2127
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`asked in her comments why no rationale for dose escalation
`• Dose Escalation: •
`was provided? No clinical data - only observations - exist to support dose
`escalation helps the patients to tolerate higher doses of BG12, no rationale will be
`provided.
`• Dose Reduction: The team discussed the question of allowing subjects to dose
`reduce vs. discontinuing the study due to tolerability issues. Study C-1900
`allowed subjects to reduce to 120mg TID for 1 month if they could not tolerate
`their assigned dose level ofBG12. After 1 month the subject would re-challenge
`at the higher dose level, if unable to tolerate the higher dose level following re(cid:173)
`challenge, subj ects would be allowed to continue the study at the reduced dose of
`120 mg TID.
`o GON and MY are in favor of allowing the same dose reduction process in
`301 and 302 and allow subjects to stay in the study at a reduced dose (120
`mg TID) if unable to tolerate the 240 TID level. MY stated she would
`prefer to have data on subjects taking some level/amount ofBG12 vs. data
`on subjects who are not on any treatment or have subjects discontinue the
`study.
`o CL questioned what impact would allowing a lower (120 mg TID) dose
`level have on the dose rationale for 240 mg TID?
`
`Page 2 of3
`
`
`
`questioned if there would be a risk to the label with allowing
`o -
`decreased dose?
`o Safety -
`noted that tolerability issues would need to be reported as
`AEs as they were in C-1900 in order to document reason for reduced
`dosing.
`o Although, not all concerns with dose reduction were resolved, it was
`agreed a section regarding dose reduction will be included in the protocol.
`Language to be taken from C-1900.
`
`Due to time constraints the team was not able to discuss issues specific to the I 09MS302
`protocoL
`
`Page 3 of 3
`
`
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