Studies
RX-RIX-CS101, RXRG001, RIX and Hyposalivation
This is a first-in-human clinical study to evaluate the safety, tolerability and efficacy of RXRG001 administered in the ducts of the parotid glands in adult patients with radiation-induced xerostomia (dry mouth) and hyposalivation (reduced saliva production).
In Part 1 of the study (open-label, single-arm), patients will receive unilateral administrations of RXRG001 in 3 single ascending dose cohorts and in 3 multiple ascending dose cohorts.
Part 2 of the study has a randomized, double-blind, placebo-controlled design. Patients will receive bilateral administrations of RXRG001 in 3 multiple ascending dose cohorts.
A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of AAV2-hAQP1 Gene Therapy in Participants with Radiation-Induced Late Xerostomia
This study will assess the efficacy and safety of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.