The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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Konar/Chester,
Think we have to be a bit careful here. Unless I'm mistaken, we were only told that 16 patients had been recruited on 3rd Dec during Lindy Durrant's Proactive One2One presentation. No patients have been recruited since but
we haven't been told that recruitment has been halted/suspended/stopped. All we know is that no patients have been dosed over the past few weeks. We've been told this is largely due to Omicron and of course Christmas fell in the middle of that period. For all we know they have still been actively trying to recruit but have been unable to get any patients through screening - worth noting the inclusion criteria for the trial. It's not just that patients can not have been infected themselves, but also they must have had no known exposure to SARS-CoV-2 virus in the last 14 days. So if they have had any contact with anyone who tested positive for Covid in the last 2 weeks, they have to be excluded.
I agree it's disappointing, but unless there was a conscious decision to officially halt the trial, I'm not sure there was any obligation (moral or regulatory) on Scancell to either inform the market or amend the study status from recruiting. Worth noting that the University of CapeTown Lung Institute still has an appeal for patients to join the trial on its website and the SAHPRA still shows the study as recruiting.
What's matters now is how quickly they can get recruitment back up to speed and how quickly they can move onto dosing with SCOV2 and move towards commencing the UK arm.
I agree that expecting trial data today was expecting too much, and that mid February was always more likely.
My big frustration here is that:
1 - We weren't told about this sooner. Its been nearly 3 months since we were told 16 patients were recruited, and the suspension of recruitment is significant.
2 - The BoD must have known this was the last date that they could push out disclosure of this materially significant news. Why did they not have a pre-booked interview with the likes of pro-active, to explain the situation and what they are doing about it? To me it just seems like they have kept this information hidden, and then failed to explain it or justify it.
I imagine I am like a lot of shareholders, I am getting increasingly frustrated by the continuous moving timelines and the failure to deliver meaningful trial data (whilst also being sympathetic to the global situation). Take this line for example:
"The Directors believe that the Company is well-funded and its diverse pipeline, based upon its proprietary platforms, is on track to deliver multiple value inflection points over the next 18 months."
This statement (or a version of it) has been in every financial update for as long as I can remember! Way past time to actually deliver on this - imvho.
I am really amazed that we were told 16 volunteers were enrolled by Prof. Durant back at the end of November and then the next day the trial enrollment stopped.
Obviously Scancell cannot dictate to the clinic in South Africa, how they have had to deal with their Omicron infections is under their responsibility .
The very thing that Covidity may impact upon is stopping trial.
From what has been said the trial should be back up and running ASAP.
For those that keep on pointing the finger at Scancell for the delays it shows a complete lack of the facts, in fact it shows a misunderstanding of the difficulties of running such a trial in the middle of a pandemic.
I always thought the Covidity safety read out would be by the middle of February so the fact we still have 24 volunteers to enrol is just an unforeseen delay.
MODI1 First patient dosed will probably land mid February as well.
Chester.
No, same old, same old.
"Ruck - red dot appears at last ? ."
Great, I'll re-read it and see if there is any news now.
Ruck - red dot appears at last ? .
Thanks Ruck - that seems plausible.
Perhaps it doesn't qualify for a red dot as it doesn't contain any new news?
The RNS is there but no red dot ! Yet.
Prof Lindy Durrant, Chief Executive Officer, Scancell, commented:
"We are pleased to report a period of strong operational progress for Scancell with two vaccine candidates now in the clinic. In October 2021, we initiated our COVIDITY programme in South Africa and to date have recruited 16 patients with safety and immunogenicity data due during H1 2022. Post-period, we successfully dosed our first patient in the SCIB1 Phase 2 clinical trial and look forward to recruitment accelerating once the impact of COVID-19 on the NHS is reduced. We have also continued to progress our antibody platform whilst expanding operationally with new laboratory and office facilities in Oxford. We would like to thank our shareholders for their continued support over the past 6 months and look forward to updating the market on future progress."
"Four clinical centres in the UK now operational in the Company's SCIB1 Phase 2 clinical trial and, post period, the first patient was dosed at Churchill Hospital, Oxford University Hospitals Trust."
Bingo !