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. Symptoms include quality of life issues such as difficulty eating, chewing, swallowing, speaking, oral pain, tooth decay, sore throat, and difficulty sleeping and exercising. Currently, there is no treatment for people with moderate or severe xerostomia.
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.
Find more information about this clinical trial at clinicaltrials.gov
