Repeated by BP on 21/09/23
MSB will commence a second phase 3 trial in adults and children >12 years of age with
acute GvHD who have failed on steroids and a second line agent including ruxolitinib (JAK
inhibitor). This single arm study in approximately 70 patients will include primary endpoint
of day 28 survival in addition to an appropriate potency assay.
The trial is expected to cost MSB in the range of US$6-$9m (mid single digits). BM-CTN
will conduct the adult trial and meet some of the funding requirement.
First patient enrolment is likely in 1QCY24. The adult market is ~10x the size of the
pediatric market, hence we estimate this trial could complete enrolment within 6 to 9
months.
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Repeated by BP on 21/09/23MSB will commence a second phase 3...
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