Ann: First patient dosed in Phase 1 bile tract cancer trial, page-57

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AlCp

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10/07/24

16:22

Post #: 74693940
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Originally posted by Fact Finder ↑

Hi E
The answer is actually in the paragraph itself.

This was a Phase 1 trial. Like all FDA trials how they are to be conducted is set out and strictly adhered to. In the present case the Complete Responder was in the intertumoral arm and received a mid level single dose directly into the tumour.

The Stable Disease responder was in the intravenous arm and received a single dose which even if it were a similar mid level dose to the Complete Responder would have likely resulted in a smaller dose reaching their tumour.

As this trial was primarily about safety Imugene was limited to the single does approved by the FDA and can only move to the next Phase once the data from this Phase 1 is gathered and considered by the FDA as being sufficient to allow further safe investigation. They cannot adhoc decide to give another dose or doses depending upon how the participant responds.

Clearly the FDA was satisfied as they have proceeded to dose their first patient for bile duct trial as announced today.

As for what happened to the Stable Disease responder we do not have any data and there are a number of options before we can conclude their disease progressed causing their death. We know that these trial participants had all failed prior lines of therapy and in effect had reached the end of the line. These participants would all have been very unwell. This participant having had his disease stabilised for four months may have had improved general health through being able to take nutrition and engage in some level of activity. It may well be that at the end of the four months they were once again fit enough to undergo some further treatment or even surgical revision if such was their desire.

The participant who had the Complete Response from the single intertumoral injection should as they say count their lucky stars because they all aligned to provide them with a result which they likely never thought possible going into this trial.

The participants in the Phase 1 trial were likely all taking part with a view that their participation might one day prevent some other poor sole ever having to suffer what they had gone through. Every day around the world selfless individuals like these take part in Phase 1 trials with their only expectation being that it might help others in the future.

My opinion only DYOR

Fact Finder

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So why is @Mason14 using this data cut to deliberately calculate the very low ORR in his calculation lol.

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