On the HC CYP thread we do our best to satisfy the needs of all the... silent... readers... out there.
Today's challenge:
Has Cynata recruited all 16patients for its Phase 1 clinical trial in SR-aGvHD in the UK as claimed by @Sector?
A very tough nut to crack (please don't look at the post I am currentlyreplying to...)!!
I had to call in the experts for that one:
Unfortunately, the experts weretoo busy to even reply to my "desperate-cry-for-help" emails.
I have also tried to reach Scotland Yard, Sherlock Holmes and Snoopy, but yeah, nah.
I was left with no option but to get to the bottom of this myself!!
The link in the original HC post is no longer working since the NIHR website has beenredone.
After a few emails to [email protected], I believe to have found the answer,sitting in the nationalarchives, patiently waiting to be read again:
https://webarchive.nationalarchives.gov.uk/ukgwa/20181102172021/https://www.nihr.ac.uk/news-and-events/features/behind-the-research/Stem%20cell%20research%20in%20GVHD.htmIn case you are too lazy to scroll to the bottom of the page:
“[…] One of the key challenges for this trial isthe unpredictability of recruitment due to the rarity of the patientpopulation. With a target of recruiting 16 patients in total, Dr Kelly explainswhy Cynata decided to bring the study to the UK:
“When we started planning we didn’t have aparticularly strong view on where we would conduct the study. We were keen todeliver it here in Australia, but we knew this would be difficult because thetarget patient population is so small, so we were quite open to extending thetrial overseas as well.
“We picked the UK after speaking to a number ofregulatory authorities in the UK, Europe and in other regions. We found thatthe Medicines and HealthcareRegulatory Agency (MHRA) was particularly helpful and very pragmatic in terms of what they required from us to be able approve the clinical trial in the UK. They provided very clear guidance about what we needed to do in terms of pre-clinical testing. This led us to the conclusion that we had a good chance of getting the trial approved in the UK quite quickly, compared to some other countries where the journey may not have been quite as smooth.
“We also looked at the recruitment potential andthe quality of clinical research sites in a number of countries. Again, the UKticked that box very well because there are a number of leading clinicalresearch centres and investigators who indicated an interest in the studyduring our early feasibility assessments.”
Being a small life science company, Dr Kelly’s teamdecided to engage a global Clinical Research Organisation, with headquarters inthe UK, to help deliver the trial. Joe Booth is a Regulatory Affairs Associatefor The Clinical Trials Company (TCTC) - the CRO which managed the study in theUK and conducted the initial feasibility. Joe believes that Cynata made a wisechoice when they decided to work in the UK:
“The UK is the ideal destination for this study.When you are dealing with a rare disease, the population density of a countryis really important. In the UK we have many high density population cities suchas London, Bristol, Leeds, Nottingham, Manchester - which made the recruitmenttarget achievable. Australia’s population is a third of the UK’s and spreadacross a much larger area, making it harder to engage patients with rarediseases.”
This fact became a reality when the study gotunderway in the UK and in Australia in March 2017. Originally Cynata had hopedto open four sites in each country, but it quickly became apparent that acompeting study in Australia could seriously hinder recruitment efforts in thesouthern hemisphere. In response, Cynata decided to open just two sites inAustralia and five sites in the UK. The combined UK recruitment target was toenrol ten patients, but the UK sites easily exceeded this target andsuccessfully recruited 16 patients by May 2018. […]”
The date appears to be in line with the following ASX announcement:
https://app.sharelinktechnologies.com/announcement/asx/f394b14aef133e9e0bd8d9d300c0448f
Time to call it in:
Thank you for your time!
Feel free to grab yourself a flyer on the way out:
CRNBDM-CS_cynata-stemcell_2018.pdf
There is also a piece of humble pie waiting at the door to go with it. Since we get the usual visitors over here that can't seem to get enough of it, it might be best to share the recipe for you so that it can be enjoyed at home as well:
https://www.kingarthurbaking.com/recipes/humble-pie-recipe
Let me know if you are in need of a consistantly good coffee to go with it. I may just know the place to get it from.
Enjoy!
P.S.: Due Diligence vs. Diligence (over)Due
P.S.P.S.: Semantics vs. Pathetics
(20min delay)