jCyte, Inc. Advances to Pivotal jCell® Trial for Retinitis Pigmentosa in 2024

A leading biotechnology firm, jCyte, Inc., has achieved a significant milestone in its mission to restore vision for individuals suffering from retinitis pigmentosa (RP) and other degenerative eye conditions. The company recently held a productive pre-phase 3 Type B meeting with the US Food and Drug Administration (FDA) on January 16, 2024, and is set to initiate a critical trial for its innovative cell therapy, jCell, in the latter part of the year.

jCyte's CEO, John Sholar, has expressed his contentment with the FDA's positive feedback on the company's phase 2/3 clinical trial proposal, including the acceptance of the primary endpoint and the dosage levels of jCell that will be used in the upcoming study. Sholar also appreciated the FDA's response to jCyte's Chemical, Manufacturing, and Control (CMC) program overview. He stated that the company is ready to proceed with the pivotal US trial, with participant enrollment scheduled for the second half of 2024, and promised to share further details at the appropriate time.

Dr. Paul Sieving, a prominent figure in the field of ophthalmology and former director of the National Eye Institute at NIH, showed his enthusiasm for the upcoming trial, highlighting the potential of the therapy to make a significant impact.

Dr. Henry Klassen, Co-Founder and President of jCyte, emphasized the importance of this development in the ongoing search for an effective treatment for RP. He praised the company's team for their dedication and innovation, which have been instrumental in reaching this crucial point in the development process.

jCyte is a clinical-stage biotechnology company that is developing a groundbreaking allogeneic cell therapy known as jCell, designed to treat RP and other retinal degenerative diseases. The treatment has been granted the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and is administered through a minimally invasive intravitreal injection. Currently, there are no FDA-approved treatments for the vast majority of RP patients, and jCyte is at the forefront of developing regenerative therapies to meet the substantial unmet medical needs of those affected by a range of retinal degenerative conditions.