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Cars,
Here is the link which posted today
https://www.sharecast.com/news/aim-bulletin/scancell-to-begin-scib1-uk-trial-as-fda-issues-linger-in-us--6948038.html
ATB
Bu
Cars, This is all I can find dated yesterday I think,
16:30 11/09/20
10.97%
1.27p
Immunotherapy developer Scancell announced the initiation of and further updates to the ‘SCIB1’ phase 2 trial in patients with metastatic melanoma also receiving the checkpoint inhibitor ‘pembrolizumab’ (Keytruda) on Monday.
FTSE AIM All-Share
954.09
16:30 11/09/20
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The AIM-traded firm had said in April that it had received the necessary regulatory and ethical approvals to initiate the UK arm of the SCIB1 clinical trial.
It confirmed on Monday that operational activities for clinical centre initiation in the UK had now been completed, while in the US, the Food and Drug Administration (FDA) had requested additional information from Ichor Medical Systems on the ‘TriGrid 2.0’ electroporation delivery system.
While there had been “extensive” dialogue between Ichor and the FDA, Scancell said a timely resolution to the device-specific questions had yet to be agreed.
In order to initiate patient recruitment in the UK under the Investigational New Drug (IND) application submitted to the FDA, prior approval of the IND was required.
Scancell said that, having considered the ethical issues related to patients awaiting enrolment into the UK sites, it had decided to withdraw its IND application in the US to allow the UK arm of the trial to proceed.
Scancell said it would resubmit the IND at a later date, with the intent to initiate clinical sites in the US, following further clarification from the FDA regarding Ichor's TriGrid 2.0 delivery device.
It said the phase 2 study was designed to assess whether the addition of SCIB1 to pembrolizumab would result in an improvement in the tumour response rate, progression-free survival and overall survival in 25 patients with advanced melanoma, who were also eligible for treatment with pembrolizumab.
Professor Poulam Patel, chief investigator for the SCIB1 phase 1 and 2 clinical trial and professor of clinical oncology at the University of Nottingham, would now be the chief investigator for the phase 2 study.
Patient enrolment into the UK arm of the study would begin immediately.
“We are pleased to be able to advance our SCIB1 phase 2 trial in the UK as we believe that SCIB1 administration with an immune checkpoint inhibitor such as pembrolizumab has the potential to offer greater efficacy than when either agent is used alone,” said Scancell chief executive officer Dr Cliff Holloway.
“Whilst it is disappointing that discussions in the US have taken longer than anticipated, we will continue our dialogue with both Ichor and the FDA, and plan to resubmit the IND as soon as possible.”
Professor Poulam Patel, chief investigator, added that there remained an “urgent need” for improved therapies in melanoma.
“Based upon our previous successful trial with SCIB1 alone we are excited to see if the addition of SCIB1 to current, standard treatment with pembrolizumab increases our anti-cancer
Ruck,
Yes, I know it was an older presentation, but apart from the mention of "OK" many times I could clearly see LD's enthusiasm
If LD is excited then I am too!
Just remember that this type of R&D takes a while..... we are not too far away though!
Should I top up a little? I think my average must be around the 15p mark, so still slightly diluted
ATB
Bunsie
Ray,
It's been like this for as long as I can remember, used to look forward to Friday Fight Nights, as you say amusing at times
You are spot on regarding filtering out the rubbish though. For me a very large proportion of the science over the last 8+ years came from Inan (Mr Abrasive) and for that I am grateful.
Oooh, it' Friday too
ATB
Bunsie
AB.... Re your 11.46, a good question
Perhaps.... Inanaco has been posting excellent information on the science from the outset (8+ years) in a very direct, no nonsense way. This may lead to a number of other posters (that may have been "shot down" by him) to take every opportunity to "have a go".
Burble... he has a more moderate way about him and is a relatively fresh poster and so far has not taken anybody on on this BB yet.
FWIW I would like to have them both posting on the science without the constant attacks and snipes at Inanaco, can't understand what it actually achieves , just clogs up the BB and causes posts to be removed.
Just my opinion though, others may have a different slant on it.
ATB
Bunsie
Latest news from the Mail
https://www.dailymail.co.uk/news/article-8717791/AstraZeneca-know-year-end-vaccine-works-trials-restart.html?ito=push-notification&ci=32982&si=16040395
ATB
Bunsie
This is my little worry taken from a post from Burble..........
Other mechanisms which may result in us not seeing synergy involve lack of interferon-gamma responsiveness in tumour (i.e. CD4+ (Th1) T-cells being unable to do their job) - Loss of the interferon-gamma responsiveness also would affect CD8+ cells and could render SCIB1 ineffective entirely), other mechanisms include things like changes to the tumour microenvironment to name a few.
I therefore believe, only time will tell when it comes to trials as to whether it is a success or not. From a commercial side of things, if a combination trial failed (especially if it lead to patient deaths) that most likely could be the beginning of the end for the ImmunoBody platform – even if technically it was caused by the Keytruda and the underlying immunobody platform was safe and well tolerated, I think investor confidence would be knocked significantly which would harm the business as a whole. With all pharma companies their cash runway is what will keep them in business long enough to either get taken over or take their product all the way through trials alone and into the clinic.
Would be a shame if we "crash and burn" from other product collaborations.
Sorry to be negative, but there is a risk there IMO.
Time will tell though
ATB
Bunsie
Here is the link for the whole article, if anyone wishes to read it!
https://theconversation.com/halting-the-oxford-vaccine-trial-doesnt-mean-its-not-safe-it-shows-theyre-following-the-right-process-145837
Burble, can you expand at all on the below?
There’s been no official statement on the nature of the incident that caused the trial to be halted. We only know it was a suspected adverse reaction in a participant in the UK. (Phase 3 trials for the AZD1222 vaccine have been taking place in several countries.)
The New York Times has reported the participant was diagnosed with transverse myelitis, an inflammatory condition than affects the spinal cord and can be sparked by viral infections.
Transverse myelitis is very rare, with between one and eight new cases per million people per year.
Most people will recover, but may be left with some symptoms such as weakness.
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In the world of vaccine safety, transverse myelitis is one of several conditions collectively known as a serious acute neurological episode (SANE) temporally associated with vaccination. Others include Guillain-Barré syndrome and acute disseminated encephalomyelitis.
“Temporal” suggests they occasionally occur some time after vaccination, but we don’t know whether the relationship is one of cause and effect. Unfortunately, it’s not always easy to find what caused these conditions, and it’s important to look for other infections that may be associated with the diagnosis.
There are a couple of things worth noting in this case. First, in the UK branch of the trial, not all participants were receiving the AZD1222 vaccine. To ascertain its effectiveness, researchers have given a control group a type of meningococcal vaccine (MenACWY) that has already been licensed. As the trial is double-blinded, we don’t yet know whether the affected participant received the COVID-19 vaccine.
Second, AZD1222 is not a “live-attenuated” vaccine — it’s not made from live SARS-CoV-2 virus. (It does use a chimpanzee adenovirus vector, but this doesn’t replicate or cause disease in humans.) It’s not impossible the transverse myelitis — if confirmed as a diagnosis — was related to the vaccine. But it wouldn’t be possible for the vaccine to cause a COVID-19 infection, which could then spark the myelitis.
Afternoon Ray,
I would like to add that I rely on the posters that contribute to understanding the science as this is IMO what it is all about, so please include those that have been here posting for more than 8 years.
I will not list them all simply because we LTH's know who they are.
Having said that, I enjoy the new feed of information from Burble, absolutely great stuff.
ATB
Bunsie
Burble,
Many thanks for taking your time to enlighten me and perhaps others, very much appreciated
Thank you.
PS, off topic, but have you looked at the latest small Spanish clinical trial on the benefits of Vitamin D regarding Covid19? I am taking daily doses as it's cheap and safe .
ATB
Bunsie