No, mRNA COVID-19 vaccines work differently than our investigational gene therapy ST-920:

• mRNA COVID-19 vaccines use lipid nanoparticles instead of viruses to deliver the genetic information (mRNA) to produce a part of the COVID-19 virus (SARS-CoV spike (S) Antigen). This protein is produced inside the cell and the immune system can create a response against COVID-19 infection. mRNA COVID-19 vaccines cannot cause COVID-19 infection.
• ST-920 uses parts of an Adeno Associated Virus (AAV). AAVs cannot cause infection to humans and are therefore a good gene therapy vector to deliver our investigational gene therapy.

If you have been vaccinated and you are eligible to participate in the STAAR study, you will need to wait 4 weeks after your last vaccine dose to receive the ST-920 infusion.

For more information on COVID-19 vaccines, we invite you to visit the Government of Canada COVID-19 website. Whether or not to vaccinate is a medical decision and should be discussed with your doctor.

No, we encourage participants to be vaccinated but this is not a requirement to participate in this study.

For more information on COVID-19 vaccines, we invite you to visit the Government of Canada COVID-19 website. Whether or not to vaccinate is a medical decision and should be discussed with your doctor.

Yes. If you have been vaccinated and you are eligible to participate in the STAAR study, you will need to wait 4 weeks after your last vaccine dose to receive the ST-920 infusion.

Medical advances depend on participation of people in clinical studies, and every participant in a study makes a positive contribution towards learning more about medicine and future medical treatments, particularly for rare diseases where fewer patients are available to help. People who enter into clinical studies are contributing to the generation of data that may advance future treatments for the benefit of more patients.

Clinical research studies are regulated, following rules set by the Health Products and Food Branch (HPFB) of Health Canada. The research study will follow a protocol, which is a detailed study plan explaining what researchers will do in the study.

Each research study must also be approved by an Ethics Committees (EC). EC consist of groups of people who help protect the rights and welfare of people participating in research studies. EC are usually made up of doctors, scientists, religious representatives, and other medical and non-medical people.

You do not have to be involved in this study to have treatment for your Fabry disease. Your other choices may include continuing your regular Fabry disease therapy, starting an approved therapy or taking part in a different study.

Your participation in the study is voluntary – you can change your mind about being in the study at any time. You must tell the study doctor or study staff if you want to stop.

While you may decide to leave the study, please understand that the administration of a gene therapy is not reversible. For this reason, you may want to continue to be monitored for possible side effects and undergo health checks even after you decide to leave the study.

All patients who have passed the screening stage and enter into the STAAR Study will be assigned to receive the investigational gene therapy ST-920. However if there are unforeseen circumstances, such as stopping the study for safety reasons, then not all eligible patients may receive the study drug.

In addition, even if you have passed all of the screening tests, there is a possibility that you will not be enrolled in the study if the study has already recruited the required number of participants who meet all the inclusion requirements.

No, you do not need to stop your Enzyme Replacement Therapy (ERT) infusions. However, the study team will want to discuss the timing of your ERT infusions, as this has to be taken into consideration when scheduling your ST-920 infusion and blood samples.

If you are willing, and if it has been at least 4 weeks after your administration of ST-920, you may be able to withdraw from ERT administration. The study doctor will explain this in more detail when you next meet to discuss your potential participation in STAAR.

Stopping ERT is completely optional, and you do not have to stop ERT to participate in the study. However, you will not be able to take a chaperone therapy, like migalastat, during the STAAR clinical study.

Your privacy will be protected. We will keep your participation in this research study confidential to the extent permitted by law and will otherwise only disclose your private and personal information based on any permissions you grant us.

The study doctor will discuss confidentiality with you in detail during the next stage of your discussions about the trial.

All study medication and study-related care will be at no cost to you. You could also receive reimbursement for travel.

You will not be paid for being in this study.

The following patient groups provide information about Fabry disease:

Canadian Fabry Association

1964 Hawkridge Drive
Thunder Bay, ON
Canada
www.fabrycanada.com

Fabry International Network

www.fabrynetwork.org