Ann: Race Appoints George Clinical for Phase 1 Trial of RC220, page-94

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MongooseMan

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16/07/24

07:03

Post #: 74766161
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Originally posted by RaceOncology: ↑

The main reason for the lower starting dose is we have no human safety data on the toxicity of the combination of bisantrene and doxorubicin. If this was a single agent trial then we would be able to start with a much higher dose of RC220, but since it is a combination trial we have to be cautious in case there is some unexpected toxicity signal. I should add we haven't seen anything in any of the various animal studies we have done that would suggest there would be any unexpected toxicity, but since this is human lives we are talking about you have to make safety paramount. I would add the animal data suggests that even a very low amount of bisantrene is able to provide some cardioprotection.

In regard the Phase 3 trial (Cowen 1991), you have to go past the abstract and read the actual paper in depth. I have never seen such a disconnect between what the abstract says and what the actual paper shows. My only guess is that Lederle were able to strongly influence the abstract to cover their backside for their decision to end the commercial development of bisantrene (the paper was published 3 years after bisantrene was dropped). When you add in that the comparison was between unlimited cycles of doxorubicin (totally unethical now) and bisantrene, I would expect that if the trial was repeated today that bisantrene would blow doxorubicin out of the water in efficacy purely because you can give basically unlimited cycles of bisantrene while you would be limited to 4 cycles of doxorubicin.

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fair enough , I had only the abstract to refer to, the full paper was not freely available. It's an ancient study as you allude to.

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Ann: Race Appoints George Clinical for Phase 1 Trial of RC220, page-94

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