jCyte announced presentations at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting, identifying a predictive biomarker for the upcoming phase 3 study for jCell therapy in retinitis pigmentosa.
A detailed analysis by the Cleveland Clinic Cole Eye Institute identified central foveal thickness (CFT), measured by spectral-domain optical coherence tomography (SD-OCT), as an anatomical marker for response to jCell, which jCyte believes will be an important factor in the inclusion criteria for the phase 3 pivotal study.
The group of patients who received the high-dose treatment of 6 millions cells, a correlation was seen between the outcomes and the optical coherence tomography (OCT) baseline parameters, i.e., the mid-subfield mean ellipsoidal zone (EZ) thickness and the mean central foveal thickness (CFT). EZ recession and more generally the thinning of the outer zone have become potential structural surrogates for RP severity.
“The identification of these important structural predictors of response aligns scientifically with the RP patient population expected to respond to jCell treatment based upon its paracrine mechanism of action,” Sunil Srivastava, MD, from the Cleveland Clinic Cole Eye Institute, lead investigator for the OCT analysis, said in a company news release. “These results are very encouraging as we know that jCell releases an array of well-established neurotrophic factors that have been shown to support photoreceptor function and survival in key preclinical models of RP and other retinal degenerative disorders when administered early in the disease process, prior to the significant loss of key retinal cell layers.”
“These findings are very promising given the magnitude and breadth of visual function improvements seen 12-months post treatment in the target population across all of the clinical trial endpoints included within our phase 2b trial, four of which measure important, distinct and objective attributes of functional vision in RP patients,” Dr. Shannon Blalock, Chief Executive Officer, jCyte, said in a company news release. “We look forward to working closely with our scientific advisory board (SAB) and principal investigators to apply these key learnings to our upcoming pivotal trial of jCell to optimize its probability of success in an effort to advance the clinical development program of our RMAT designated therapy for RP patients who currently have no treatment options.”