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
21 Feb 2024
Phase 3Cell Therapy
NEWPORT BEACH, Calif.--(BUSINESS WIRE)--jCyte, Inc., a pioneering biotechnology company dedicated to preserving and restoring vision in patients with retinitis pigmentosa (RP) and other degenerative retinal disorders, is pleased to announce the successful outcome of its pre-phase 3 Type B meeting with the US Food and Drug Administration (FDA) held on January 16, 2024. Additionally, the company is gearing up to commence its pivotal US trial for jCell in the second half of 2024.
John Sholar, Chief Executive Officer of jCyte, expressed satisfaction with FDA’s review of the planned phase 2/3 clinical trial design including FDA’s approval of the primary endpoint and the two jCell doses to be included in the study. Sholar was also delighted with the FDA’s responses to jCyte’s description of its CMC program. “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.”
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, was enthusiastic about the news, stating, “I am looking forward to seeing this promising therapy move into a US pivotal trial.”
Henry Klassen, MD, PhD, Co-Founder and President of jCyte, acknowledged the significance of this achievement in the quest for a treatment for patients with retinitis pigmentosa. “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.”
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 over 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 .
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