RE: Endo's En3348(MCC) trial - Complementthis new trial is not to compare Urocidin to BCG . Its a trial where Urocidin - or EN3448 - is used where there is some failure of BCG treatment
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"Subjects with either
recurrent or refractory NMIBC (Ta high grade, T1 low or high grade, CIS) will be eligible for participation in this study.
Refractory disease is defined as failure to achieve tumor-free status by 6 months of initiation of adequate BCG therapy (minimum of 5 weekly doses of BCG (induction) followed by a second course (induction or maintenance) in which subject received a minimum of 2 doses).
Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months after initiation of adequate BCG therapy. Subjects with recurrent disease must have recurred within 18 months following the last dose of BCG. "
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It remains strange, IMO, that this trial compare Urocidin to an antibiotic which is not used - as far as I know - to treat cancer. On the other hand, it is true that Urocidin wont get approved before the first year of this trial, so it will be theoritically unavailable
Since it was clear that FDA required safety data to give a GO to Urocidin - Phase IIIa -, I suppose that this is the reason of this trial
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In fact, I could never figure out how those safety data could come from Phase IIIb since it is supposed to be a long term double blind study, so you have to wait to the end of the trial to unblind data