If you had radiation therapy for your head and neck cancer, your glands that produce saliva were probably damaged by the radiation. If you have dry mouth (xerostomia) and not making enough saliva (hyposalivation), the condition you have is called “radiation-induced xerostomia (RIX for short) and hyposalivation”.
Do you suffer from
Radiation-Induced Xerostomia
and Hyposalivation?
What is the SPRINX-1 Study?
The SPRINX-1 Study is a clinical research study for people with dry mouth (xerostomia) and not making enough saliva (spit), called hyposalivation caused by radiation therapy of head and neck cancer. The condition is called “radiation-induced xerostomia (RIX for short) and hyposalivation”.
The purpose of this study is to see if the investigational new gene treatment, RXRG001 (study drug), has an effect on dry mouth symptoms and the amount of saliva produced, and to see if it is safe and well-tolerated in people.
The study drug is investigational, which means it is still being studied. The regulatory authority of the US Food and Drug Administration (FDA) does not currently allow it to be sold as a therapy for xerostomia. The FDA and central and local ethics committees have approved the conduct of the SPRINX-1 Study.
What is the study drug?
The study drug, RXRG001, contains ribonucleic acid or RNA for short. RNA is present in your body’s cells in many forms, and it helps your body to make proteins that are essential for bodily functions. The type of RNA in RXRG001 helps your cells to produce a protein called aquaporin 1 (AQP1) that allows water to flow from inside of cells to outside of the cells, and to the mouth. RXRG001 also contains a fatty substance (lipid) that helps the RNA get into your cells so it can make the needed protein.
Who can participate in the SPRINX-1 Study?
Study participants must meet certain criteria* to qualify for the study:
-
18 years old or older
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You must have had a history of radiation treatment for stage >2 head and neck cancer
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You must be free from recurrence of your cancer and never have had another form of cancer for at least 2 years
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You must be suffering from xerostomia and/or hyposalivation and have xerostomia symptoms which were not resolved after treatment for at least 5 months
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You must have both parotid glands on imaging examination within a year
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You cannot have any active infection
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You cannot be in heart failure, kidney failure or uncontrolled diabetes
(Hemoglobin A1c >8%) -
You cannot have a history of autoimmune diseases known to potentially affect the salivary glands,
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You cannot be an active smoker or use tobacco products or have a history of substance or alcohol abuse
*Other criteria apply
Why Participate in SPRINX-1 Study?
By taking part in this study, you may be helping to make a new treatment for other people suffering from the same disease as yourself.
How many participants are in the study?
This study will include about 42 participants at about 5 clinics in the US.
Where can you find a Study Site?
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