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jCyte announces pivotal trial of jCell for RP to start in second half of 2024

News
Article

The treatment is a minimally invasive intravitreal injection that can be performed with a topical anesthetic.

Gloved hands holding vial and needle Image Credit: AdobeStock/desertsands

Image Credit: AdobeStock/desertsands

Biotechnology company jCyte announced in a news release the positive pre-phase 3 FDA type B meeting that took place on January 16. The pivotal trial of jCell to treat retinitis pigmentosa (RP) is scheduled to start enrollment during the second half of 2024.1

According to the company website, jCell is a first-in-class allogeneic cell therapy in late-stage clinical development for treating RP. The treatment is a minimally invasive intravitreal injection that can be performed with a topical anesthetic.2

The treatment provides sustained release of neurotrophic factors that reduce photoreceptor cell death and promote functioning of surviving photoreceptors. jCell therapy preserves vision by intervening in the disease when host photoreceptors can be protected and potentially reactivated. Unlike gene therapy approaches, jCell does not target any specific genotype.2

jCyte’s goal is to make jCell the first approved cell therapy to address this critical unmet medical need, and dramatically improve the lives of patients with this degenerative retinal disease.2

jCyte chief executive officer John Sholar said in the release, “We are pleased with the FDA’s review of the planned phase 2/3 clinical trial design, including FDA’s approval of the primary endpoint and the 2 jCell doses to be included in the study.”

Paul Sieving, MD, PhD, the Neil and MJ Kelly Professor of Ophthalmology at the University of California Davis School of Medicine and immediate past-director of the National Eye Institute at the NIH, is looking forward to seeing this promising therapy move into a US pivotal trial.

Henry Klassen, MD, PhD, cofounder and president of jCyte, acknowledged the significance of this achievement in the quest for treating patients with RP. “This is a major step in our long journey to treat RP. We are all eager to get this treatment to patients,” he said in the release.

References:
  1. 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. jCyte. News Release. Published February 21, 2024. Accessed February 22, 2024. https://www.jcyte.com/news/press/2024-feb-21/
  2. jCell Therapy: A novel approach for treating blinding diseases. jCyte. Updated 2024. Accessed February 22, 2024. https://www.jcyte.com/science/#overview
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