These are very good points about stepping through the clinical...

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18/12/21

11:25

Post #: 58383831
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Originally posted by stockrock: ↑

Just to give some context, the patients we are treating who have recurrent glioblastoma .. on average die within 6 months after reoccurence.

So as you can imagine, the window to recruit is very narrow.. and made more difficult by the fact that these patients are extremely sick and cannot travel too far. So time and distance is a big factor.

Add to that, once the patient is identified.. screened and then blood taken, it takes around a month to culture enough CAR-T cells for the treatment... so they could either progress too much in that month to allow treatment, or the patient dies in that month they were waiting for the treatment.

So it's not a matter of them going slow for safety, they can do as many as they can at a given time.. concurrent dosing is permitted. It's the supply and time constraints they are working with.

So naturally if they have 3 centres instead of 1, what took 6 months to recruit.. should in theory only take 2 months. That is of course when those two new trial sites are up and running, which is due early 2022.

And in terms of a pivotal phase 2 trial being run before the phase 1 is complete? that's a very bad idea... you may save 12 months, but you may blow up the entire trial and have to start all over again.

The purpose of phase 1 studies is to establish safety, but also the optimal dosage for the phase 2 pivotal trial. They'll also learn more about patients and who responds better... thus being able to screen their patients better to ensure those being treated have the best chance of a response.

The other biotech we hold is being criticised for not designing its phase 3 trials correctly... that's easy to say in hindsight, but you can sense it here.. when you are in the earlier phase trials... you want to go fast, you want to just get trial results ASAP. That leads to errors and things being missed... so it's already hard to get trials designed properly at the best of times... rushing through is almost setting yourself up for failure.

I think those investing in early stage biotechs really need to think about how long this is going to take, and be prepared for a long ride. Results will come, but it will take time. The best thing the company can do for us is to do things well and do them right the first time. I'd rather a positive result in 24 months, than a bad one in 12 months.

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These are very good points about stepping through the clinical trial phases in an orderly fashion and taking forward as many learnings from one phase to the next. This is particularly important in the emerging era of precision medicine where we need to zero in on responders and evolve trials accordingly.

The CHM team are highly experienced with this - they really are a rock star team which ticks yet another of my investment boxes.

CHM Price at posting: 28.0¢ Sentiment: Buy Disclosure: Held
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These are very good points about stepping through the clinical...

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These are very good points about stepping through the clinical...

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