Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AAV2hAQP1: 1 x 10^11 vg/gland · 1 trial · 3 indications
Safety will be assessed by number of adverse events occurring with treatment
| Arm | Type | Description |
|---|---|---|
| 1 x 10^11 vg/gland (single gland) | EXPERIMENTAL | - |
| 3 x 10^10 vg/gland (both glands) | EXPERIMENTAL | - |
| 3 x 10^11 vg/gland (single gland) | EXPERIMENTAL | - |
| 1 x 10^11 vg/gland (both glands) | EXPERIMENTAL | - |
| 1 x 10^12 vg/gland (single gland) | EXPERIMENTAL | - |
| 3 x 10^11 vg/gland (both glands) | EXPERIMENTAL | - |
| 3 x 10^12 vg/gland (single gland) | EXPERIMENTAL | - |
| 1 x 10^12 vg/gland (both glands) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AAV2hAQP1: 1 x 10^11 vg/gland (single gland) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to a single parotid gland at a dose level of 1 x 10\^11 vg/gland |
| AAV2hAQP1: 3 x 10^10 vg/gland (both glands) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 3 x 10\^10 vg/gland |
| AAV2hAQP1: 3 x 10^11 vg/gland (single gland) | DRUG | Intra-parotid administration of AAV2hAQP1 of via Stensen's duct to a single parotid gland at a dose level of 3 x 10\^11 vg/gland |
| AAV2hAQP1: 1 x 10^11 vg/gland (both glands) | DRUG | intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 1 x 10\^11 vg/gland |
| AAV2hAQP1: 1 x 10^12 vg/gland (single gland) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to a single parotid gland at a dose level of 1 x 10\^12 vg/gland |
| AAV2hAQP1: 3 x 10^11 vg/gland (both glands) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 3 x 10\^11 vg/gland |
| AAV2hAQP1: 3 x 10^12 vg/gland (single gland) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to a single parotid gland at a dose level of 3 x 10\^12 vg/gland |
| AAV2hAQP1: 1 x 10^12 vg/gland (both glands) | DRUG | Intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 1 x 10\^12 vg/gland |
Inclusion Criteria: 1. Male or female subjects ≥18 years of age. 2. History of radiation therapy for head and neck cancer. 3. Abnormal parotid gland function as judged by both absence of unstimulated parotid salivary flow and a stimulated parotid salivary flow in the targeted parotid gland \>0 and ...