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I agree no news is good news RE the covidity trial but can someone explain the timelines of when we could possibly hear something?
Also, purely IMO, assuming trial is going ok (and the fact Omnicron has suddenly come to the fore), then I feel there must be lots going on in the background RE conversations with external parties. Could that also explain why we've not heard anything so far?
https://www.scancell.co.uk/Data/Sites/1/media/docspres/scancell-2021-agm_all_final_corrected.pdf
see slide 16
This shows a 6 month trial and I recall that Lindy said that this is a minimum.
Then I think she said 6 weeks to collate and publish results.
Only at that point would Scancell be looking to partner up.
Having said that they may well have had preliminary discussions with possible partners.
As far as we are concerned, we may not hear anything until after results are published.
The same slide also shows the UK arm of the trial (Scov2 as booster). With its positioning on the slide does this mean it is due to start some point after the dosing of Scov1 in SA has finished on all 40 patients? So we may get news of the UK ARM starting and that may also be a good indication that the SA trial is going to plan.
Ray, I am not trying to dampen enthusiasm here but feel we should “inject” (excuse the pun!) some reality or pragmatism here.
Why would the UCT Lung institute start advertising for volunteers for the Covid trial last Thursday if they have the number of patients they need to move the trial forward?
It suggests to me that they are short on numbers and therefore a potential delay may be caused and if the market believe this to be the case, then that may be the reason why the SP is holding circa 20p.
Slower progress does not mean failure!
I agree Kash. The trial will take a minimum of 6 months and IMO will certainly take longer.
Judging by the timing of that advert, it looks like they have not yet recruited 40 volunteers.
My understanding is also that, from slide 16, the 6 months starts when all 40 have received their first jab.
The trial may be taking on a different dimension due to the events of the last few days. It is certainly an opportunity not to be missed. Right time and place springs to mind.
However, the new lab should be receiving blood samples which will be analysed for antibody and T Cell levels.
It cannot be said whether or not we get an RNS for these preliminary analyses.
Please correct me it wrong, but I thought the reports back from the AGM were that all trial participants have had first doses and second doses had been started?
Maybe the advert is because the trial is being extended or rolling immediately into a phase 3, or maybe an admin oversight?
"Maybe the advert is because the trial is being extended or rolling immediately into a phase 3, or maybe an admin oversight?"
On that point, when we got the first trial participant dosed RNS, they wouldn't have started the trial without knowing they had the 40 candidate cohort in place would they?
Also with Omnicron, things could move much much faster now I assume.
As i understood it, Lindy stated that the 2nd doses had begun. i don't believe it was reported that 1st doses had all been completed. The 2nd doses will be given according to the dosing schedule defined in the trial protocol. So the 1st patient will have their 2nd dose on day 29 (28 days after first dose) irrespective of if all 40 patients have been recruited. Each patient will have their own dosing time table based on when they were recruited.
It is every bit possible that the 1st patient will have had their 2nd dose before all 40 recruits have had their 1st dose, depending on the success of the recruitment. The criteria for inclusion and no exclusion are pretty long, so I imagine quite a few people will be rejected on these:
https://clinicaltrials.gov/ct2/show/NCT05047445?term=Scancell&draw=2&rank=1
They also would have started dosing the first patient without identifying all 40 participants in advance. Someone could become ineligible for the trial whilst waiting for other participants to be recruited. The old "Grab em and Jab em" approach wins here.
AIMHO
It's pretty disappointing though if we can't get 40 participants for a vaccine trial in a country
(sorry clicked post by accident)
It's pretty disappointing though if we can't get 40 participants for a vaccine trial in a country... that currently has low vaccine roll out % and growing case numbers. Hopefully Omicron will give recruitment a boost.
the only other view i would make on the trial, is that Omicron may turn out to be a double edged sword for the trial. On the one hand we may get accelerated recruitment, and we also have a potential opportunity to demonstrate that covidity can work against an additional strain. On the other hand, our headline trial results will no doubt be compared with the 1st generation vaccines against the original pandemic. So in other words, if SCOV2 *would* have resulted in a 99% protection against Alpha, Beta or Delta, but *only* achieves 80% against a now dominant Omniron, then this could be perceived as failure in the public eye who are used to seeing approved vaccine figures in the 90%+.
I'm pretty sure Scancell would have preferred that the ground hadn't moved under their feet in South Africa in the way that it has, but I am sure the Scancell team will already be working to determine the likely clinical impact that omicron may have.
…..” the only other view i would make on the trial, is that Omicron may turn out to be a double edged sword for the trial.”
But also Omicron variant with its very mild form can be the silver lining and a key in accelerating Herd immunity that leads to the end of pandemic quicker than anticipated…
Well ..time will tell…and let’s hope we get rid of this horrendous disaster which destroyed so many lives,businesses and our way of life…
Konrad, the whole USP of scancells approach is that it is being advertised as being largely effective against the vast majority of mutations so this latest mutation (as far as scancells testing period is concerned) couldn’t have come at a better time.
As long as it does what we have been told It can do in the clinical trials then it will showcase to the world what a massive advantage they have over the current vaccines and future mutations.
Just imagine the world wide cost savings if the major pharmaceutical companies don’t have to change their vaccines every 4 to 8 months.
That’s hundreds of billions saved, not to mention the cheap manufacture and storage costs.
Apologies konar, my spell check kicked in.
Yes roses agreed.. its a double edged sword. Best case scenario (I'm talking purely from a Scancell perspective here - not the unfortunate people that would be effected) would be for Covidity to show an ongoing high % of immunity where the 1st generation vaccines show a significant drop.
Not forgetting the needle-free administration of the vaccine. Big saving in many ways in addition to everything else.