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good points phantom1 but disagree with the point that these...

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cdoyle

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07/09/23

14:02

Post #: 69770410
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Originally posted by Phantom1: ↑

I am interested when posters keep say "We know the drug works" This is correct, but only so far.

It has some effect historically (not with either the formulation or MOA that RACE now will be using, so not helpful or usable in any regulatory sense), in AML, and in the lab as a cardioprotective and as a version of a CPI (FTO etc).

What RACE does not know are the answers to the following questions (not exhaustive, just illustrative). These are the questions I ask myself when thinking about the company.
1. What dose to use? The CPI/FTO, cardioprotective and direct chemotherapy approaches will use markedly different doses to get the different therapeutic effects needed. You can not get the benefit of all three at the same dose.
2. Do you use the agent as a stand-alone FTO or need to use it with a T-cell therapy (absolutely in my view- see the original paper)
3. Do the FTO, cardioprotective approaches work at all in humans - no trials done, are any about to occur to test this? Without human clinical data showing MOA and hopefully efficacy the program is quite weak.
4. Does the cardioprotective effect only work on healthy heart cells or can it be used in second/third-line treatments after heart damage has already occurred? This will require several trials to tease out.
5. Are you sure there is no diminution of the traditional chemo effect when the agents are used together for cardioprotective? Lab results say probably not - may in fact help- but again not human data. Initial trials will need to be rescue / already injured hearts, not the first line until this is very clear.
6. What are the pharmacokinetics of the new formulation? What will be the optimal dosing schedule? Do we have a manufacturing process to the level required by FDA and pharma (ie scalable and cost-effective)?
7. Will we see precipitation, phlebitis or anaphylaxis side effects as was the case with the previous version (the traditional formulation that did not get commercialised).

These are the sorts of questions that need solid answers before any Pharma will look at RACE with any interest at all.

All of these questions can be answered of course. My point is that they still need to be and it will take very good people a lot of time and money.

Last question, do you have the people in Race to optimally do this work (not the easy finance/corporate work -the slow, hard, necessary science and trial work)

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good points phantom1 but disagree with the point that these questions need to be answered before any pharma is interested. Assets are bought out from start of preclinical through to p3. all these questions need answering but it doesn’t necessarily preclude commercial interest

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