Link – Why the ION717 trial is paused
from: CureFFI.org
from: CureFFI.org
April 6th, 2024
We have been advised that Ionis has paused recruiting for their ION717 Human Clinical Trial for Prion Disease (CJD, GSS, FFI).
We want to be clear that the study continues – only recruiting of new patients is paused at this time. We have not been advised at this stage when recruiting will commence again.
Please understand that this is not uncommon in research. Please see below for the Ionis Community Statement relating to the pause.
April 9th, 2024 – Ionis has released the following community statement on the PrProfile clinical trial recruitment pause:
March 26th, 2024 – Ionis has just announced the activation of a site in Gunma, Japan for the PrProfile Study.
You can learn more about this site here: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717.
As always, individuals interested in learning more about the trial/site information can contact PrionDisease@clinicaltrialmedia.com and/or call +1- (844) 221-3587.
March 25th, 2024 – Ionis has just announced the activation of a site in Tel Aviv, Israel for the PrProfile Study.
You can learn more about this site here: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717.
As always, individuals interested in learning more about the trial/site information can contact PrionDisease@clinicaltrialmedia.com and/or call +1- (844) 221-3587.
March 19th, 2024 – Ionis has just announced the opening of two enrolment locations in Japan – one in Tokyo and the other in Yamaguchi for the PrProfile Study.
You can learn more about this site here: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717.
As always, individuals interested in learning more about the trial/site information can contact PrionDisease@clinicaltrialmedia.com and/or call +1- (844) 221-3587.
March 13th, 2024 – Ionis has just announced the opening of an enrolment site in Montreal, Canada (McGill University Health Centre) for the PrProfile Study.
You can learn more about this site here: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717.
As always, individuals interested in learning more about the trial/site information can contact PrionDisease@clinicaltrialmedia.com and/or call +1- (844) 221-3587.
February 21st, 2024 – Ionis has just announced the opening of an enrolment site in Boston, USA (Massachusetts General Hospital) for the PrProfile Study.
You can learn more about this site here: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717.
As always, individuals interested in learning more about the trial/site information can contact PrionDisease@clinicaltrialmedia.com and/or call +1- (844) 221-3587.
February 3rd, 2024 – Ionis has just announced the opening of an enrolment site in Germany for the PrProfile Study. This is the third site to open outside of the USA.
You can learn more about this site here: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717.
As always, individuals interested in learning more about the trial/site information can contact PrionDisease@clinicaltrialmedia.com and/or call +1- (844) 221-3587.
January 27th, 2024 – Ionis has just announced the opening of an enrolment site in Barcelona, Spain for the PrProfile Study. This is the second site to open outside of the USA.
You can learn more about this site here: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717.
As always, individuals interested in learning more about the trial/site information can contact PrionDisease@clinicaltrialmedia.com and/or call +1- (844) 221-3587.
January 24th, 2024 – Ionis has announced that they have opened a third enrollment site in Canada (University of Alberta) for the PrProfile Study.
You can learn more about that site here: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717.
Anyone interested in learning more about the trial/site information can contact PrionDisease@clinicaltrialmedia.com and/or call +1- (844) 221-3587.
As of January 20, 2024, the UCLA Neurology Clinic in Los Angeles, California, United States has been added as the next prion disease human clinical trial site.
Please email PrionDisease@clinicaltrialmedia.com or call (844) 221-3587 to obtain more information on the study details and clinical trial site locations.
Nina Oberbeck from Gate Bioscience at the 2023 CJD Conference, Melbourne Australia.
“Small Molecules to eliminate Prion proteins”
The status of the Ionis Clinical Trial on clinicaltrials.gov is now “Recruiting“.
One site is listed as active and recruiting at this time and that is in the U.S. at the University Hospitals Cleveland Medical Center in Ohio.
Key points:
Remember, this is just a first step in a very long process. Research does take time but each step leads us closer to discovery. Regardless of the outcome, this is a positive step for those impacted by prion disease.
Please find below links to some general information on clinical trials which may be helpful in the lead-up to the commencement of clinical trials for prion disease:
U.S. Department of Health & Human Services – Participating in Human Research
You may find the videos to be very approachable, and they have a very handy PDF with questions that people should consider asking a study investigator. Many of their resources are available in English and Spanish, which is a nice bonus!
U.S. Food & Drug Administration – Clinical Trials: What Patients Need to Know
Explanations are very basic, but include special pages on Informed Consent and explain the difference between a trial and medical treatment which is very helpful, especially for communities like ours that are relatively new to trials.
U.S. National Institute of Health – Clinical Research Trials and You
This site has some great tools as well, although they may be a little bit more technical that the Health & Human Services ones.
First details of Ionis trial disclosed
Here is the link: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717
The current status is “not yet recruiting”. Even though no sites are open, this is a normal step in the process. You are able to see some of the study criteria and other information.
We will continue to provide you with updates as things progress.
So nice to see a member of our prion research community acknowledged. Many of you, who have donated funds in memory of your loved ones to the CJDSGN to support our prion researchers in Australia, would have helped provide funds for some of Andy’s work.
From Cosmos Studio
From: Optometry and Vision Sciences at University of Melbourne Facebook page –
Via their social media channels:
LinkedIn: Australian Government Department of Health and Aged Care’s Post
X:
? Sunday is International Creutzfeldt-Jakob disease Awareness Day – #CJD is a rare & serious disease causing the brain to degenerate, leading to dementia & death. Did you know that globally most CJD occurs sporadically? ? https://t.co/X0NIR6rKAZ pic.twitter.com/bUuOV05aiF
— Australian Department of Health and Aged Care (@healthgovau) November 9, 2023