1 CONSENT:
You will have in-depth conversations with the doctor and read a detailed information sheet about the study to see if it is right for you, what will be expected from you, and the potential risks and benefits.
FLT201: AN INVESTIGATIONAL ONE-TIME THERAPY
THE GALILEO-1 GAUCHER CLINICAL Trial
If you’ve been living with Gaucher disease Type 1 (GD1), you’re all too familiar with its effects. If you’re taking one of the currently approved therapies for GD1, you may have a lifetime of treatments ahead of you, and even with treatment, you may still have symptoms.
The GALILEO-1 clinical trial is studying an investigational one-time therapy that has been designed to continuously deliver the enzyme missing in people with Gaucher disease.
YOU MAY BE HERE BECAUSE …
You’ve lived with Gaucher disease for most of your life.
You’re tired of watching a loved one suffer.
You’re looking for an alternative to your current treatment.
You’re interested in the possibility of a one-time treatment for Gaucher disease.
You understand that being part of a study may help the Gaucher community.
You want access to investigational treatments that are not yet available to the general public.
Are you living with Gaucher disease Type 1?
See if you qualify for the GALILEO-1 clinical trial.
ABOUT THE GALILEO-1 GAUCHER TRIAL
WHY THE STUDY IS IMPORTANT
Clinical trials are an essential step in the development of new treatment options. The GALILEO-1 clinical trial seeks to gather data about FLT201, an investigational one-time therapy for adults with Gaucher disease Type 1.
PURPOSE OF THE STUDY
The trial will primarily assess the safety of the investigational therapy. It will also gather data about how well the investigational therapy works.The findings could support the advancement of care and may provide an alternative treatment option for the Gaucher community.
PATIENT JOURNEY
WHAT CAN PARTICIPANTS EXPECT?
GALILEO-1: Investigating
a one-time therapy
1
2
3
4
1
CONSENT: You will have in-depth conversations with the doctor and read a detailed information sheet about the study to see if it is right for you, what will be expected from you, and the potential risks and benefits.
2
SCREENING:
Various blood tests, scans, and questionnaires will be conducted to ensure you are eligible to take part in the trial.
3
INFUSION: Under the care of your medical team, you will receive the one-time infusion. While the infusion takes only 1-2 hours, there are additional tests and assessments done before and after as part of the clinical trial.
4
FOLLOW-UP:
Your medical team will monitor how you are doing on an ongoing basis by asking how you are feeling and conducting blood tests, scans, and questionnaires. These check-ins are frequent at first and then reduce in frequency over time.
DO I QUALIFY?
You may be eligible to participate in
the GALILEO-1 trial if:
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You are diagnosed with Gaucher disease Type 1. |
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You have had at least 2 years of ERT or SRT. |
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You are a man or woman 18 years or older. |
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You are not pregnant or nursing. |
TRIAL LOCATIONS
Find a clinical trial site near you.
Brazil
Porto Alegre – Hospital de Clinicas de Porto Alegre
Dr. Ida Vanessa Schwartz
idadschwartz@gmail.com
tel: 55 51 999017418
Germany
Höchheim – SphinCS
Dr. Eugen Mengel
info@sphincs.de
tel: 49 6146 904820
Israel
Jerusalem – Shaare Zedek Medical Center
Ari Zimran
azimran@gmail.com
tel: 972 2 6555143
Tel Aviv – Tel Aviv Sourasky Medical Center
Dorin Trigubov
dorint@tlvmc.gov.il
tel: 972 3 6974905
Spain
Barcelona – Hospital Universitario Vall d’Hebrón
Dr. Maria Camprodon
maria.camprodon@vallhebron.cat
tel: 34 67 7072506
Zaragoza – Hospital Quironsalud Zaragoza
Dr. Pilar Giraldo
giraldocastellano@gmail.com
tel: 34 67 0285339
United Kingdom
London – Royal Free Hospital
Dr. Derralynn Hughes
derralynnhughes@nhs.net
tel: 44 02077940500
Salford – Salford Royal Hospital
Contact: Marie Meehan
Marie.meehan@nca.nhs.uk
tel: 07799797743
Principal Investigator: Dr. Reena Sharma
United States
Fairfax, VA – Lysosomal Storage Disorders Research and Treatment Center
Dr. Ozlem Goker-Alpan
Lauren Noll
ogoker-alpan@ldrtc.org
lnoll@ldrtc.org
tel: 1 703-261-6220
Los Angeles, CA – Kaiser Permanente
Dr. Divya Vats
DIVYA.VATS@kp.org
tel: 1 323-361-5704
ARE YOU A PHYSICIAN TREATING PEOPLE WITH GAUCHER DISEASE?
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Are you interested in knowing more about the GALILEO-1 study of FLT201? Learn more at clinicaltrials.gov. |
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Are you interested in participating in the trial as a clinical investigator? Reach out to clinicaltrials@spurtherapeutics.com. |
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Do you have a patient interested in participating in the clinical trial? Contact the closest clinical trial site to learn more about enrolling your patient. |
FAQ
What is a clinical trial?
A clinical trial is a research study that investigates a medical treatment or therapy in people. The findings of a trial will be used to determine how safe and effective a treatment is and how it can be best utilized.
How long will my participation last?
Your treatment team will closely monitor you for a period of time after you receive the investigational therapy. Following this, all people who have received the therapy will be followed for at least five years.
Would I have to travel to the site to be assessed?
Yes. There are a number of essential tests that must be run at the trial center, however some can be done at your home. You will not be responsible for travel costs, but it is important to consider how participating in the study may fit into your lifestyle and other commitments.
What are my options if I can’t travel to one of the trial sites but want to be considered for the study?
We continue to add trial sites to the list so check back again for a center that might work for you. If this study doesn’t work for you, there may be other opportunities to be involved in research. Your current doctor may also contact the trial sponsor Spur Therapeutics at clinicaltrials@spurtherapeutics.com to inquire about additional studies of the investigational therapy FLT201.
Are there any costs to participating in the trial?
The investigational therapy, medical appointments and assessments, and any travel required to participate in the study are provided at no cost to you.
What else should I know about participation?
Participation in a clinical trial has both benefits and risks. The full details of possible benefits and risks will be provided by a doctor at the clinical trial site. Participation in this study could lead to advancements in the care and treatment of Gaucher disease. At this stage in the treatment’s development, not everything is known about it, which is important to understand before enrolling. Talk to your doctor about any concerns you may have.