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Stu
Why are u back? have you bought back in or are you still trying to drive this further down with questions over funding again?
We know they will need money but not for some time and trials will start once they have a patient enlisted so the short is probably opened with one of your mates to create uncertainty again and drop the price further.
It would be great if you don't answer but that is unlikely as you are ALWAYS here for a reason !!!
Actually i’d agree with Haywain’s thoughts on first patient likely outcome and so Ph1 patient trial, IF and when it happens, is not my main concern.
The interim period and funding is!
The large short position opened is not mine and like others, i have no idea when news will drop on just how and when the funding issue will be addressed.
Mr I, please give it a rest with the stale Mcap argument.
JFH over did it too and look what position he’s now in !?
AIMO
DYOR
Ps I’ll not be replying .
I mostly agree on what should move things, but there is guaranteed to be some punters who arrive (via a pump party) speculating on a quick turn on Hemo if the first patient is a success…. And 4 years from now they’ll be posting on this forum moaning about life.
Morning all
Volume has ticked up this morning & needed to after last 2 weeks thin vol
I suspect a blue north finish today after touching 1.52
Poor with the potential
Let’s see what coming weeks bring
Day 2 of the LSX World Congress in London - I hope Vlad is attending this.
https://informaconnect.com/lsx-world-congress/
Its a sad day when we have to rely on stu for news on hemo !!! Groundhog every day since funding news ... whats the news on the trials ... all like mushrooms in the dark here
Only thing is. Only proper actual news will move this. News about the trial starting isn't really news is it. Or CBR pump isn't news. People are switched on now. Only positive news regarding a patient will send this north. I fear any silly news will pi ss people off and it will drop
Stu are you going long or short..!! It's defo no coincidence some sort of news must be on the way in the next few weeks.
Stu is here. Means one thing. Trial has failed and best sell up. 100% he has inside info
Haywain,
Thank you for the response.
It appears fair and unbiased , although with a positive slant as you openly admit.
More of the same might benefit this board.
AIMO
DYOR
Poolbeg Pharma are working on drug to reduce CRS.
Thanks HK very helpful report !
This paper is better as it is about CAR T-cell phase 1 trials.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9400039/
Here's some basic information about clinical trials for anyone who is interested. There are many research papers available on Google scholar about dose escalation studies too.
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are/phases-of-clinical-trials
@hemoknowledge
When/how is it decided to escalate the dose?
@stu
Almost all CAR T-cell treatments cause Cytokine Release Syndrome (CRS), perhaps all. Naturally, the grade of CRS is important (1-4). Five to eight years ago, grade 3-4 were unacceptable. Nowadays, grade 3 is tolerable and sometimes even grade 4 can be managed, though it is considered to be life-threatening.
My understanding is that phase 1 is a dose escalation clinical study with safety as primary readout. This means that the researchers will start with the lowest dose of cells. This will allow them to avoid life-threatening situations. This also means that it is highly unlikely that the first patient will cause the termination of the study.
Stewy darling, just a thought, what do you think the chances are of a small meteorite entering your rear end and exiting through your gob, thus rendering you a sad lifeless vegetable ? Nice if it happened.
STU485...just wtf is wrong with you???
You are correct in noting that Phase 1 trials are primarily designed to evaluate safety and tolerability, rather than efficacy. The emphasis on efficacy in my posts was driven by a common interest in the potential treatment outcomes, but this certainly should not overshadow the importance of safety data.
Regarding the typical CRS incident rate in CAR-T treatments it varies widely depending on the specific CAR-T construct and the patient population. Generally CRS occurs in approximately 50% to 90% of patients treated with some of the more common CAR-T therapies like those targeting CD19 in B-cell malignancies. Most cases are mild to moderate and manageable with standard treatment protocols including the administration of tocilizumab an IL-6 receptor antagonist approved specifically for severe CRS.
With regard to whether or not the trial would be stopped if the first patient where to react with severe CRS? I think it would depend. It is of course a possibility, however If the CRS was severe but could be managed effectively with standard protocols (as has been the case for some other approved CAR-T therapies) and measures could be taken to mitigate future risk the trial could continue with adjustments and would need to be discussed with FDA/ethics committee. I do have a tendency to focus on the positive because I am positive about Hemo's product candidates but in the interests of balance there a risk that the trial could fail because of safety reasons.
Haywain, your recent posts regarding Ph1- first patient are all efficacy related.
We all know Ph1 is predominantly a safety study, so why no mention of safety stats?
In your defence and on a very quick look, I can’t see any asking for your scientific and unbiased opinion on safety, so let me please.
Could you please advise the typical CRS incident rate with Car T treatments ?
Also, in the unfortunate event of a severe CRS incident in Patient 1, do you believe the trial would continue?
Thanks in advance.
AIMO
DYOR