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usual adult dose for soft tissue sarcoma
note: several dosage regimens exist for this drug. the information presented here is manufacturer recommended dosing. some cancers are more responsive to this drug than others. always consult institutional protocol.as a single agent: 60 to 75 mg/m2 iv over 3 to 10 minutes every 21 days
the 21 days are there to allow recovery from a massive list of horrendous side effects, amongst which it's killing healthy heart tissue.
today's rns confirms that the first cohort which received 160 mg/m2 of ava6k over a two week period (i think that's higher than a standard dose of dox, bv wil confirm) have seen no adverse safety issues.
that in itself is remarkable, yes it's only 3 patients but if they had had straight dox then in my experience they would be in a terrible state.
the final cohort in the 3 week study was 3.5 times a standard dose. again amazing, with very limited side effects.
but of course today's message gets lost again in amongst the ******.
It's not necessarily about the concentration that goes in, nor indeed the concentration achieved in the TME.
It's about how long it's in the TME and actually it really all about whether it's more clinically effective in the chosen indication than straight Dox.
And that we don't know and can't know until the Phase 2 trial.
It's an inconvenient truth, but there you go, it is what it is.
That may well be true but what you’re getting with Avacta at this stage is everything you could ask for - impeccable safety and strong *signs* of efficacy as seen by the tumour reductions.
There’s already clear evidence that AVA6000 will vastly reduce side effects so even a small improvement in efficacy and what we have here is a blockbuster drug.
It's well beyond standard dosing Timster. Given the more frequent dosing it's equivalent to 240mg over 3 weeks which is almost the same as cohort 5 already. CC compared to standard dox and it's avoiding the dose limiting severe side effects and also reducing quality of life side effects, which she was particularly excited about. Dox will be dox and there's plenty of it where it needs to be, it's already an improvement and as Doc Tap said, that's makes it the SoC overnight. It's just a case of being patient whilst the trial completes.
We have had multiple patients with high FAP tumours getting blasted for months on end at various cohort levels the case study the dude was on trial for 11 months and was still on it 1st of May it’s the cumulative dose that’s important. Continued exposure to the TME without the cardiovascular toxicity. Keep the FUD coming Thorn. It’s hilarious 😆.
I agree, even if it's not as effective as standard Dox if it can be given in a weaker/frailer and more ill patient with perhaps co morbidities or pre existing cardiac disease it'll find a place and a market.
Will still need Stage 2 clinical trials to know, that's the bottom line.
Thronogson, I think you have remember that once cleaved in the TME, Dox then behaves like Dox and will have the same half-life as straight Dox but will begin in much higher concentrations in the TME. There is no doubt that the PK data and the biopsies both indicate that AVA will supply the TMA with more Dox than standard Dox and more will be present in the TME for a longer period of time as that is where the drug begins it's half-life.
The 2 week dosing period wasn't chosen at random, it was extrapolated from the data. As PL75 says, there is already plenty of it in the right place, well over the therapeutic concentrations for it to have anti tumour activity. The 2 week dose will only increase this further. However, if it was deemed that this still isn't sufficient, then the dosing regimen could be shortened as much as necessary to further elevate the levels in the tumour, all the while keep the levels in the blood plasma significantly lower than for a straight dose of dox.
Can't see why thorn is still arguing the toss on that one. It's heads, deal with it.
"Can't see why thorn is still arguing the toss on that one."
Because he's a fluck1n moron!
'I agree, even if it's not as effective as standard Dox if it can be given in a weaker/frailer and more ill patient with perhaps co morbidities or pre existing cardiac disease it'll find a place and a market.'
So do you agree that it's looking extremely positive? We have what's looking like a worst case scenario as you described above and a best case scenario (maybe via 2 week dosing) of a far safer AND more effective chemo.
No the worst case scenario is that it's not clinically very good at all compared to Dox, that's why Phase 2 trials are needed.
That'll take time and money++.
Clues that all is not well?
- Sudden exit of Chief Development Officer without explanation.
- Changes to the trial design
- Sudden departure of CEO without explanation
- Heavily discounted Fund Raise which included a Specialist European Fund with full access to data/developments to date (I presume).
- Ongoing share price drift/decline since the raise (Good news has a habit of leaking out as does bad).
I see Eggy is desperately trying to regain some credibility after his highly embarrassing outing earlier today!? LoL
Hang on HarChris, is that really what the sulphuric moron is saying? The argument that DOX will not be as effective as DOX? I mean, there's stupidity and then there's not understanding the basic premise of the platform in that it delivers toxic drugs such as DOX to the TME. It's delivering DOX to the TME with reduced side effects. Zero debate. IT WORKS.
You strike me as someone that spent all their time at the uni debating society picking the extreme side and finding great enjoyment in challenging themselves to come up with some sort of coherent counter position. Today you've dug in deeper than you ever have to the point of stretching things far beyond reality.
How about this... AIM companies, due to their lack of institutional backing, very rarely manage to remove a long standing founder and CEO without failure having become so egregious that their position is deemed untenable. That's what we're essentially dealing with here, a platform with such massive potential that a discounted placing, even in this environment, is simply so inexcusable that he was forced out. In addition to lacking the necessary business skills to prepare Avacta for a BP TO in the years ahead.
I'm sure you understand why it has been handled the way it has and why a lack of commentary is the most beneficial path forward but of course there's nothing like silence as an excuse to spin your own yarn,
The SP is NOT all about the science.
IIs won’t invest because they know what is coming. In my post “careful what you wish for” I predicted IMHO the next step after arm2 results have been analysed and that is:
Novartis will buy us for 50p per share plus one Novartis share for every 160 Avacta shares we own. And at the current SP that is a good deal.
Harchris
Al was forced out but not because of the fire sale at 50p. That was a condition imposed by Novartis for securing necessary funds to carry us through to the TO. The writing was on the wall when they parachuted in CC and Simon to manage the deal through.
Eggy strikes me as the type that didn’t go near a uni, except to stalk student nurses
Surely all clowns use a unicycle.
Touk, would you care to explain why your prediction carries any more weight than a pom pom girl's prediction of £5 per share?
£5?? CC needs to give the cheerleaders a lesson.
Give a 50…. 50!
Give a 50…. 50!
Give a 50…. 50!
Give a 50…. 50!
What’s that make? 200!
Who does that exclude? Chin-ah!
21 mins in.......https://www.youtube.com/watch?v=NhVMmNN1wx0
Is Qu1nt the bell end still posting on here ?
TOUK
I would not be happy with that deal that you suggest.
Gje306
Sorry only just got back from pub
You are right this is just my analysis of the past two years and a prediction.
I think that Al’s problem was the same as mine - the tech is so good it has to be a winner. But it is too revolutionary and the procedural system doesn’t allow for such a targeted treatment. Al believed that after cohort 1 had shown unbelievable safety he would be allowed to increase dose levels in much larger steps anticipating an end to P1a at cohort 4. But of course he wasn’t allowed to do that. Then of course patients weren’t selected to show efficacy (it was a safety trial after all) so anti tumour activity was variable and didn’t meet the hype that preceded it. Safety alone wasn’t enough to secure BP licensing of the platform and Al was quickly losing credibility.
I believe Novartis had already been “selected “ as a partner - see my previous posts for reasons. But hadn’t seen enough to commit hence move to arm 2 to improve the results and parachuting in CC and Simon to guide things through for a TO when arm 2 delivers convincing results. Of course Al had to go because he never wanted a TO. We possibly misread his “don’t worry about funding “ comment because he already knew he was going by then and Novartis has all the resources needed.
However Avacta did need funds to show they could reach the start of P2 at least. With Novartis standing in the wings the offer price was immaterial provided it realised enough cash to get Avacta to the point where Novartis would TO. The current SP is below 50p and unlikely to move up much until end of arm 2. In earlier posts I’ve given my reasons why there will be no bidding war so given we were trading at just over £1 before the “forced” sale I see a TO at that price as fair and I think Novartis will want it to be half cash (so investors can get their offer price back) and half shares in Novartis so they can reap some of the benefits of the success of Avacta.
OK. This is itotal conjecture but has its basis in fact and is just as valid as “huge BP takeover tomorrow £20 by the close” and other such fantasies.
Or, just as invalid as the £20 Pom Pom girls, which was the point I put to you.
You don’t really provide any basis for why you think £1 would be considered fair, nor did you broach the matter of £1 being roundly rejected by shareholders. Your conjecture exists as yet another Pom Pom fantasy, just one where the Pom Pom girls have beards and are dressed up in string vests and y-fronts.