Ann: First participant treated in the last dose escalation cohort, page-13

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Jdmoney

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22/03/24

12:31

Post #: 73012279
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Originally posted by fourdollars: ↑

That's not what I'm suggesting. Based on Wilsons view that the Phase 3 trial will involve 4 x 12GBq doses (ie consistent with the Phase 2 expansion cohort), I'm noting that elements of this trial have already been worked into the Phase 2 trial.

1. Participants in earlier cohorts have been given multiple doses (under the EAP). I know this is not officially part of the trial, but its a good sign that multiple doses are (a) safe and (b) effective.

2. Cohort 4 has been redesigned to provide for 4 doses (instead of just 2) earlier than originally planned - which again implies that multiple stronger doses are expected to be (a) safe and (b) more effective.

I'm speculating that the results to date (and subsequent) modifications to the Phase 2 trial bode well for moving 67Cu up the treatment path in Phase 3.

Would it be possible to avoid earlier treatment lines and just use 67Cu?

Dr Taylor keeps making a point that patients on the trial have already undergone multiple prior treatment lines. The implication (at least as I understand it) is that the effectiveness of 67Cu is reduced as it is being administered to significantly weakened patients who have have their cancer progress for an extended period.

Perhaps the opposite is true. Maybe 67Cu wouldn't be as effective if some of the heavy lifting hadn't already been done by the earlier treatments?

My (very uneducated) hypothesis is that if 67Cu could cure you of mCRPC without the need for chemo etc .... then this would be a preferred route for patients. And if this is the case, are there results from Phase 2 that would provide for Phase 3 to move up the treatment line?

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You need to be approved for last line treatment first before moving up the treatment ladder.

novartis have had to do another P3 trial psmafore to prove pluvicto is better than chemo. This is still pending if it is a success.

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