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Also known as AAV2-hAQP1
AAV2hAQP1 · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| single arm dose escalation | EXPERIMENTAL | single arm dose escalation |
| Name | Type | Description |
|---|---|---|
| AAV2hAQP1 | BIOLOGICAL | Infusion of gene therapy |
* INCLUSION CRITERIA: 1. At least 18 years of age 2. History of external beam radiation therapy for head and neck cancer, with a mean dose equal to or greater than 15 Gy to a parotid gland. 3. Abnormal parotid gland function as judged by both absence of unstimulated parotid salivary flow and ...
AAV2-hAQP1 is an investigational gene therapy being developed for squamous cell head and neck cancer and for grade 2 and 3 late xerostomia caused by radiotherapy for cancers of the upper aerodigestive tract, excluding the parotid glands. It is designed to address irradiation-induced parotid salivary hypofunction.
AAV2-hAQP1 is an adeno-associated viral vector encoding human aquaporin-1. It is designed to deliver the gene for aquaporin-1 to salivary gland tissue to restore salivary function in patients with radiation-induced xerostomia.
AAV2-hAQP1 is being developed by MeiraGTx Holdings plc, a biopharmaceutical company traded on the stock exchange under the ticker symbol MGTX.
AAV2-hAQP1 is in Phase 2 clinical development. It has received FDA designations including Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Breakthrough Therapy. It is investigational and not yet approved for commercial use.
AAV2-hAQP1 has been studied in two clinical trials. NCT02446249 was a Phase 1 safety study in 17 participants with irradiation-induced parotid salivary hypofunction, completed in the United States. NCT06544798 is a Phase 2 long-term follow-up study enrolling 276 participants with grade 2 and 3 late xerostomia in the United States and Canada.
Yes, AAV2-hAQP1 is also referred to as AAV2hAQP1 in clinical trial documentation. Both names refer to the same adeno-associated viral vector encoding human aquaporin-1.