Trial Profile
A Phase I/II, Multicenter, Open-Label, Single-Dose, Dose-Ranging Study to Assess the Safety and Tolerability of ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy, in Subjects With Fabry Disease (STAAR)
Status:
Active, no longer recruiting
Phase of Trial:
Phase I/II
Latest Information Update: 06 Apr 2025
Price :
$35
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At a glance
- Drugs Isaralgagene civaparvovec (Primary)
- Indications Fabry's disease
- Focus Adverse reactions; First in man
- Acronyms STAAR
- Sponsors Sangamo Therapeutics
- 17 Mar 2025 According to a Sangamo Therapeutics media release, presented updated Phase 1/2 STAAR study data at the 21st Annual WORLDSymposium in San Diego, CA in Feb 2025 showing sustained benefit, improvements in kidney function and a favorable safety profile, following a single administration of isaralgagene civaparvovec in 33 adults with Fabry disease.
- 17 Mar 2025 According to a Sangamo Therapeutics media release, company aligned with FDA on clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec in Fabry disease, using expected data from ongoing Phase 1/2 STAAR study, avoiding requirement for additional registrational study and accelerating estimated time to potential approval by approximately three years.
- 06 Feb 2025 According to a Sangamo Therapeutics media release, the Report on Form 8-K summarizing the updated preliminary results from the Phase 1/2 STAAR study in more detail will be filed by Sangamo, and this press release is subject to the further detail provided in that Form 8-K.