Approval Probability
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AAV2-hAQP1 Concentration 1 · 1 trial · 1 indication
The XQ consists of 8 symptom-specific questions the participant rates from 0 (not present) to 10 (worst possible). The XQ Total Score is the sum of all individual item ratings and ranges from 0 to 80.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: AAV2-hAQP1 Group 1 | EXPERIMENTAL | Eligible participants will receive up to 3 mL of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
| Cohort 1: AAV2-hAQP1 Group 2 | EXPERIMENTAL | Eligible participants will receive up to 3 mL of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
| Cohort 1: Placebo group | PLACEBO_COMPARATOR | Eligible participants will receive up to 3 mL of diluent via Stensen's duct to each parotid gland |
| Cohort 2: AAV2-hAQP1 Group 3 | EXPERIMENTAL | Eligible participants will receive up to 3 mL of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
| Cohort 2: AAV2-hAQP1 Group 4 | EXPERIMENTAL | Eligible participants will receive up to 3 mL of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
| Cohort 2 Placebo group | PLACEBO_COMPARATOR | Eligible participants will receive up to 3 mL of diluent via Stensen's duct to each parotid gland |
| Name | Type | Description |
|---|---|---|
| AAV2-hAQP1 Concentration 1 | GENETIC | Administration of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
| AAV2-hAQP1 Concentration 2 | GENETIC | Administration of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
| Placebo | OTHER | Administration of diluent via Stensen's duct to each parotid gland |
| AAV2-hAQP1 Concentration 3 | GENETIC | Administration of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
| AAV2-hAQP1 Concentration 4 | GENETIC | Administration of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland |
Inclusion Criteria: * Completed beam radiation therapy for head and neck cancer at least 3 years prior to the first screening visit * No history of recurrent head and neck cancer, parotid gland cancer, or a second primary cancer, except for treated basal cell or squamous cell carcinoma of the skin ...
AAV2-hAQP1 Concentration 1 is an investigational gene therapy being developed for Grade 2 and 3 late xerostomia caused by radiotherapy for cancers of the upper aerodigestive tract, excluding the parotid glands. It is intended to treat dry mouth resulting from radiation therapy in these patients.
AAV2-hAQP1 Concentration 1 is a gene therapy that uses an adeno-associated virus vector to deliver the human aquaporin-1 (hAQP1) gene. This gene encodes a water channel protein that is intended to restore salivary gland function and increase saliva production in patients with radiation-induced xerostomia.
AAV2-hAQP1 Concentration 1 is being developed by MeiraGTx Holdings plc, a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of this gene therapy for radiation-induced late xerostomia.
AAV2-hAQP1 Concentration 1 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has received FDA designations including Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Breakthrough Therapy.
AAV2-hAQP1 Concentration 1 is being studied in a Phase 2 clinical trial with the identifier NCT05926765. This randomized, double-blind, placebo-controlled trial is active but not recruiting, with an estimated enrollment of 290 participants. The study is being conducted in the United States, Canada, and the United Kingdom.
AAV2-hAQP1 Concentration 1 is a specific concentration or formulation of the gene therapy AAV2-hAQP1. The drug is referred to as AAV2-hAQP1 in clinical trial documentation, and the Concentration 1 designation indicates a particular dose or preparation being evaluated in the study.