Dear HSC Community,
You may have already heard the sad news about the Roche GENERATION HD1 clinical trial being prematurely stopped. This phase III study was designed to evaluate the efficacy and safety of RG6042 (known as tominersen). As part of the scheduled quarterly review, and with no specific new safety concerns being raised, on March 22, 2021 the study was halted early.
This is extremely disappointing and difficult news for the entire HD community, but especially for the families participating in the trial, and we appreciate that you likely have many questions. At this stage of the process there simply aren’t many answers, but we pledge to share information as soon as we can receive it. If you have questions as a trial participant, Roche is recommending that you contact your study physician directly.
We encourage you to read through the information provided by Roche. Click here for the Roche Community Statement: https://www.huntingtonsociety.ca/wp-content/uploads/2021/03/Tominersen-programme-update-Community-letter.pdf
The trusted team at HDBuzz has published an excellent article explaining more about when and why trials are stopped early, as well as next steps. Click here to read their article: https://en.hdbuzz.net/300
Whether you are a person living at risk, are mutation positive, are symptomatic of HD, or are a carer, strong emotions can surface with an announcement such as the one concerning this study. Please know there are people and places you can turn to get more information and support:
- HD Clinics: Questions specific to trial participation can be discussed with the HD clinic you attend. For information on the HD clinic near you: https://www.huntingtonsociety.ca/hd-clinics-in-canada/
- HSC Family Services (FS) are available to provide support, education on HD, resources and referrals. Individuals and families can find the contact information for the nearest FS team member here: https://www.huntingtonsociety.ca/family-services-team-list/
- Should you or a family member be in crisis, you can contact:
- Adults: Crisis Services Canada : crisisservicescanada.ca , call 1.833.456.4566 or Text 45645 (nationally)
- Youth: Kids Help Phone: https://kidshelpphone.ca/ call 1.800.668.6868 or Text 686868
- Everyone:
- Your local crisis service, or hospital emergency department
- If there is imminent danger, you can also call 911
Finally, as many of you are aware, we are holding our Virtual National Conference this weekend on Saturday March 27. Although we won’t have answers to share with you at the conference, we hope that everyone can gain some comfort from the connections, support and motivation that are the foundation of such events. Now more than ever we can use this event as an opportunity to weather the ups and downs together and keep moving toward a bright future.
Sincerely,
Shelly Redman
CEO
Huntington Society of Canada