What is the study drug?

The study drug delivers a gene designed to make a specific protein called a water channel that allows water to flow into the parotid ducts and then into the mouth to moisten it.  This water channel protein is already made naturally within your body, but the gene therapy treatment causes the protein to be expressed in the lining of your salivary glands, where it is not normally present. The study drug is investigational and is not yet approved for general use by regulatory authorities.

How long will the study last?

Study participation will last for about one year.

At the end of the AQUAx2 study, participants will be encouraged to enroll in a separate long-term follow-up study which will ensure that the health of the participants is monitored for a total of five years after receiving the study drug.

How many visits will I have to make during the trial?

There are 13 scheduled study visits. Additional visits to support assessments, such as a computed tomography (CT) scans, may need to be scheduled separately, which could require an additional visit.  There are three initial screening visits to determine eligibility, one dosing visit to receive the study drug and nine follow up visits to monitor health and safety, as well as to measure potential efficacy of the therapy.

How many participants are in the study?

This study will include about 276 participants at about 40 clinics in the United States, Canada, and United Kingdom.

Who can participate in the study?

Study participants must meet certain criteria* to qualify for the study:

  1. 18 years old or older
  2. It must be at least 3 years since your final radiation treatment
  3. You must be suffering from moderate or severe xerostomia
  4. You must be free from recurrence of your cancer and never have had another form of cancer
  5. You must not have a diagnosis of Sjogren’s syndrome, myasthenia gravis or acute angle closure glaucoma
  6. You cannot be infected with HIV
  7. You cannot have kidney failure
  8. You cannot be an active smoker and may not have used any tobacco product (including vaping) in the past 3 years
  9. You cannot have uncontrolled diabetes (Hemoglobin A1c >7%)

*Other criteria apply

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