Bear in mind that the intention for commercialisation is not to replace dox or the anthracyclines, but rather to augment them by way of protecting the heart and providing additional anti-cancer activity. In that regard, it is not necessary to show which agent is driving the anti-cancer response. If bis+dox is greater than dox alone, that is enough to show the benefit of bisantrene regardless of which molecule is actually mediating the effect.
With that said, I believe one of the intentions for the lead-in dose of the trial is to measure bisantrene's activity as a single agent. At this stage it's more of an exploratory endpoint imo.
Ann: Race Appoints George Clinical for Phase 1 Trial of RC220, page-136
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