jCyte Inc. Announces First Patients Treated in JC02-88 Trial for Retinitis Pigmentosa

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--jCyte, Inc. is pleased to announce the first patients have been enrolled and treated in the JC02-88 study evaluating the safety and efficacy of jCell (famzeretcel) for the treatment of retinitis pigmentosa (RP). The jCell dose being studied in this trial is approximately 50% higher than the highest dose administered in previous jCyte clinical trials.

Retinitis pigmentosa is a rare genetic disorder that leads to progressive loss of the rod and cone photoreceptors in the retina. There are many different gene variants. The condition is typically noticed in adolescence, with many patients becoming legally blind by middle age. It is estimated that RP affects approximately 2 million people worldwide, including about 100,000 individuals in the U.S.

John Sholar, Chief Executive Officer of jCyte, said: “The initiation of patient dosing in this trial marks an important milestone in our mission to bring a breakthrough treatment to the majority of RP patients who currently have limited treatment options. jCell has the potential to help restore vision in patients with RP, regardless of genetic subtype, and we look forward to sharing updates as the study progresses."

Paul Sieving, MD, PhD, Neil and MJ Kelly Professor of Ophthalmology at UC Davis School of Medicine and immediate past-Director of the National Eye Institute, at NIH, commented on the trial’s potential impact: “This is an exciting development for the RP community, and I am eager to see how this promising therapy advances toward providing a novel cell-therapy treatment for a patient population with vast unmet need.”

Henry Klassen, MD, PhD, Co-Founder and President of jCyte, highlighted the significance of this achievement: “This marks another critical milestone in our journey to develop a treatment for RP. Our team’s dedication and perseverance have brought us to this point, and we remain committed to delivering a therapy that can make a meaningful difference in patients' lives.”

This trial is made possible through the support of key partners, including the Gavin Herbert Eye Institute, the UCI GMP Facility, Lexitas, and the California Institute for Regenerative Medicine (CIRM).

About the JC02-88 Trial

This phase 2 trial seeks to assess the safety, tolerability, and efficacy of a single 8.8 million cell injection of jCell, a treatment designed to improve vision in patients with RP. The trial will enroll up to 60 patients aged 18 – 60 years and with any genetic subtype of RP who meet certain study requirements. Patients will receive either one jCell dose or a sham treatment (control) and will be assessed for safety and changes in vision over the 6-month study. All patients, regardless of the clinical site to which they are registered, will be treated at the UC Irvine Gavin Herbert Eye Institute. A subsequent extension study is planned following the conclusion of the JC02-88 trial to allow for longer term monitoring of all patients and so that patients randomized to the sham control group can be treated with jCell. For more information please visit the trial website at www.jcyte.com/JC02-88-study/.

About jCyte, Inc.

jCyte, Inc. is a clinical-stage biotech company focused on developing its first-in-class allogeneic cell therapy, jCell, for retinitis pigmentosa (RP) and other retinal degenerative disorders. The treatment has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation and is administered as a minimally invasive intravitreal injection. Currently there are no FDA approved therapies for approximately 99% of RP patients. The company is pioneering a new era of regenerative therapies to address the significant unmet medical needs of patients suffering from a broad set of retinal degenerative diseases. For more information, visit www.jcyte.com.

About the Gavin Herbert Eye Institute

The Gavin Herbert Eye Institute is dedicated to advancing the understanding and treatment of eye diseases through innovative research and clinical care.

About Lexitas

Lexitas is a specialized clinical research organization with over 14 years dedicated exclusively to ophthalmology.

About the California Institute for Regenerative Medicine (CIRM)

With $5.5 billion in funding and more than 150 active stem cell programs in their portfolio, CIRM is one of the world’s largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality.