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I would think it highly unethical that if there was data on activation etc that it wouldn’t be taken into consideration with regards to DE. If there data is suggesting no activation then the positivity and ‘remarkably consistent’ doesn’t make a lot of sense. My two cents… but I do think the TW offensive is remarkably unresearched and there would be easier targets on AIM.
Some excellent posts today and I agree with the view that a simple dosage increase without proper clinical justification based on the agreed patient testing results (eg urine/blood samples) makes no sense to me whatsoever. I also wanted to share this link with those who haven't seen this paper as it is such a good summary of the reasons as to why AVA6000 could be such a therapeutic breakthrough - https://febs.onlinelibrary.wiley.com/doi/full/10.1111/febs.15583
Note especially under Cardiotoxicology - 'Currently, there is no management or medication to relieve anthracycline-induced cardiotoxicity, and the only option for patients with severe symptoms is a heart transplantation. Therefore, doxorubicin is excluded from treating patients with a poor heart function, usually old patients. Thus, alleviating cardiotoxicity would greatly improve cancer treatment with anthracyclines.'
It was the bit about heart transplants that caught my attention - for some reason I had missed that aspect. So after today's news AVA6000 is another step nearer to achieving a much sort after goal that will benefit so many cancer patients in so many different ways. Long way to go yet - but at least we are heading in the right direction.
Paul Hills a bell end. Same as that other tit he does interviews with who thinks escape rooms is worth billions.
Paul Hill says 'multiple shots on goal' 50 times, soils himself with excitement, then explains that he's not invested and the SP tanks, one to avoid I suggest.
Yes Timster
But AS gets to speak in 80% of the interview and Giles 20%.
But with Paul Hill it’s Paul 80% and AS 20%
And SP still tanks :):)
@energy ah Giles with his dulcet tones, just asking questions off a sheet that AS has given him, then AS congratulating himself on asking himself a great question. Happy days......
Excellent - and thanks, as ever, for your informed input.
I kept going through the only documentation I've found for the trial (https://clinicaltrials.gov/ct2/show/study/NCT04969835) but wondered if I'd missed something somewhere else that just might clarify that one single but major point.
I also honestly can't see that it would progress if there wasn't any activation.
I'm still all in!
Maximum drug concentration (Cmax) of AVA6000 & Doxorubicin [ Time Frame: Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation) ]
Cmax (maximum plasma concentration) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
"An opinion is that it would not be allowed to continue if it just went in and came out the other end untouched."
I am also of this opinion. Why?
clinicaltrials.gov/ct2/show/NCT04969835
Secondary Outcome Measures:
3) Elimination half-life (t1/2) of AVA6000 & Doxorubicin
4) Renal clearance (CLr) of AVA6000 & Doxorubicin
At the end of the AGM presentation, when I was questioning him, AS acknowledged that the Secondary Outcome Measures in the trial (i.e. focus on Activation at TME (essentially, Efficacy)) are critical – in reality, as important as the Primary Outcome Measures (Safety and Tolerability). As such, if NONE of the SOMs were being met throughout C1 (and subsequently, C2), it would have been pointless for the SDMC to continue the trial.
Now, I note that it's not down in black and white anywhere that achieving the SOMs is "critical" to trial progression... But, 1) I trust AS' word; and 2) I like to think I have a bit of common sense. In reality, activation in TME is as important as safety and tolerability, even in P1a (i.e. proof of concept). The SOMs are, in truth, POMs – and I think the SDMC will be treating them as such.
Please Timster not Paul Hill we have tanked after every interview with him.
“Bring Back Giles”
@Drillspark
I know (and I really do believe that's the case), but I would love to be able to find that in the trial's terms in black and white, then it's game on big time!
The Yanks are coming
Wild star…..so at mega expense to Avacta they continue the clinical trial if AV 6000 is going in one end an out the other untouched……you could swallow a marble to achieve that…ffs
*would surely be
@13thmonkey (or anyone)
"An opinion is that it would not be allowed to continue if it just went in and came out the other end untouched."
Can we find this anywhere in the trial's terms etc?
That would surely the golden nugget we're looking for to solidly confirm our hopes and suspicion.
Fair enough Neut. There will be an horrible group such as him hoping this fails. Which when you consider it’s not something like simple LFT sales, but in fact a treatment for cancer, it shines a light on what an horrible rat piece of **** he is.
As a reminder (and it was highlighted at the time) according to the presentation slides from the prelims 80mg of AVA6000 = 54mg of dox so I assume 160 mg of AVA6000 = 108mg of dox.
MrR... I typed a load of crap about him pumping BOOM when its now 10% down today, OEX has been savaged too.
Everything hes pumped himself, is in the gutter.
I deleted it because hes just not worth it.
The Yanks will jump on this . GLA
Mr Rip .
re Quimt
Pointless, skin of a rhino and he'd love the attention .
Sticking with ignoring him
Paul hill does love an avacta interview hopefully lining one up
Anyone not banned from Twitter fancy giving that Quint a good roasting for me? Haha
A wee Vox interview would be welcomed either with AS or Neil, in case we manage to receive a few more golden nuggets of info.
And today's statement
The recommendation from the Safety Data Monitoring Committee to initiate dosing in Cohort 3 with 160mg/m2 of AVA6000 is an endorsement of the emerging safety and tolerability profile in the patients enrolled in this study to date.
Sorry MrA my Uber ramping continues
See, 13th
Thank you