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JCyte Moves Forward with Pivotal US Trial for Treatment of Retinal Diseases

JCyte Moves Forward with Pivotal US Trial for Treatment of Retinal Diseases

February 23, 2024

jCyte, Inc., a leader in biotechnological innovations aimed at combating retinal degenerative disorders, announced a significant milestone in its quest to bring new hope to patients with retinitis pigmentosa (RP) and similar conditions.

Following a productive pre-phase 3 Type B meeting with the US Food and Drug Administration (FDA) on January 16, 2024, the company is set to launch a pivotal trial in the United States for its therapy, jCell, in the latter half of 2024.

Understanding Retinitis Pigmentosa

Retinitis pigmentosa is a genetic disorder that impacts the retina's ability to respond to light, leading to progressive vision loss and ultimately blindness. It represents a major challenge in ophthalmology, affecting individuals worldwide. The development of effective treatments for RP is crucial for improving the quality of life for those affected by this condition. jCyte's jCell therapy emerges as a beacon of hope, with the potential to significantly alter the disease's trajectory.

FDA Approval Paves the Way for Pivotal Trials

The meeting with the FDA marked a crucial step forward, with the regulatory body reviewing and approving the design of the planned phase 2/3 clinical trial, including the primary endpoint and the two jCell doses to be studied. John Sholar, CEO of jCyte, shared his enthusiasm about the meeting's outcomes, stating, "We are pleased with the Type B meeting minutes, which enable us to move forward with the US pivotal trial. Enrollment is expected to begin the second half of this year and more information will be shared when appropriate."

This sentiment was echoed by Paul Sieving, MD, PhD, the Neil and MJ Kelly Professor of Ophthalmology at UC Davis School of Medicine and former Director of the National Eye Institute at NIH, who expressed eagerness to see the therapy progress into a pivotal trial in the US.

Henry Klassen, MD, PhD, co-founder and President of jCyte, also highlighted the significance of this development. "This is a major step in our long journey to treat RP. I am immensely proud of our team. It took a lot of hard work, innovation, and perseverance to reach this milestone. We are all eager to push on and get this treatment to patients."

A New Horizon in Retinitis Pigmentosa Treatment

jCyte's jCell therapy represents a beacon of hope for those affected by retinitis pigmentosa, a genetic disorder that leads to progressive vision loss and can result in blindness. The therapy's progression into a pivotal trial underscores the company's commitment to advancing medical science and improving the lives of patients with degenerative retinal disorders.

As jCyte prepares for this next phase of clinical trials, the biotech community and patients alike await with bated breath for what could be a landmark achievement in the treatment of retinal degenerative diseases.