The AQUAx2 Study

The AQUAx2 study is a clinical research study for people with moderate or severe dry mouth (xerostomia) caused by radiation therapy for head and neck cancer.

The purpose of this study is to see if the investigational gene therapy, AAV2-hAQP1 (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 with dry mouth as a result of receiving radiation therapy for head and neck cancer.

The study drug is investigational, which means it is still being studied. Regulatory authorities such as the US Food and Drug Administration (FDA), Health Canada, and the Medicines and Healthcare Products Regulatory Agency (MHRA) do not currently allow it to be sold as a therapy for xerostomia. These regulatory authorities and central and local ethics committees have approved the conduct of the AQUAx2 trial.

If you qualify for the study, you will be randomly assigned to 1 of 3 treatment groups. Two of these groups will receive the study drug (one of two different strengths) and the third a placebo (an inactive solution that does not contain the Study Drug). If you receive the placebo in this study, you will be offered the active gene therapy in a follow-up study that will start after the AQUAx2 study is completed.

Study Information

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