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AAV2hAQP1

Phase 1

Squamous Cell Head and Neck Cancer | Monoclonal antibody | Oncology |MeiraGTx Holdings plc|Last Updated: Sep 25, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02446249Safety of a Single Administration of AAV2hAQP1, an Adeno-Associated Viral Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in People With Irradiation-Induced Parotid Salivary HypofunctionPHASE1 ACTIVE NOT_RECRUITING 17May 4, 2015Jul 1, 2026Sep 25, 20251 United States
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Study Endpoints
Primary Endpoints
Safety of vector
36 months
Secondary Endpoints
Efficacy of treatment
36 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
single arm dose escalationEXPERIMENTALsingle arm dose escalation
Interventions
NameTypeDescription
AAV2hAQP1BIOLOGICALInfusion of gene therapy
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

* 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 ...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT02446249primaryCompletionDate: changed
LOWMay 24, 2026NCT02446249studyFirstPostDate: changed