jCyte Receives Phase 3 Approval for jCell® Therapy
jCyte has announced it has received approval to initiate Phase 3 of their ground-breaking clinical trial for jCell therapy for retinitis pigmentosa (RP) – a pivotal moment for this trial. Currently, over 99% of RP patients lack approved therapies for this progressive sight-loss disease, amplifying the significance of this approval. jCell, a first-in-class allogeneic cell therapy, has shown promise in addressing this urgent need as it holds potential benefits for individuals with various forms of RP, including those with Usher syndrome, as it targets RP broadly, independent of specific mutations.
With plans to commence Phase 3 in the US in the second-half of 2024, this trial builds on promising results from Phase 2b study, released in 2020, which showed improvements in visual acuity, contrast sensitivity, kinetic visual fields, and mobility-related visual function among many treated patients. Notably, 39% of patients receiving the high dose of 6 million cells via a single intravitreal injection, had improvement in best correct visual acuity (BCVA) of 10 letters (two lines on an eye chart) or more.
About jCell therapy: The aim of jCell therapy is to help preserve vision by protecting the remaining photoreceptors and to help them function better. Administered through a single intravitreal injection into the eye, it releases neurotrophic factors—special proteins—to shield the photoreceptors.
For further information, check out he following resources:
jCyte Inc. Announces Positive Pre-Phase 3 FDA Type B Meeting and Outlines Plans to Start Pivotal Trial of jCell® for Retinitis Pigmentosa in The Second Half of 2024: https://www.jcyte.com/news/press/2024-feb-21/
jjCyte Announces Phase 2b Results of jCell Therapy in Retinitis Pigmentosa (July 2020): https://eyewire.news/articles/jcyte-announces-phase-2b-results-of-jcell-therapy-in-retinitis-pigmentosa/?c4src=article:infinite-scroll
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