Luxa Biotechnology Announces Publication in Cell Stem Cell Describing Positive Clinical Results for First-in-Human Clinical Trial for Dry AMD Therapy
Luxa Biotechnology LLC (Luxa) today announced the publication of Phase 1/2a clinical trial results in a paper titled "Safety and Tolerability of RPE Stem Cell-derived RPE Transplantation in Patients with Dry Age-related Macular Degeneration: Low Dose Clinical Outcomes" in the journal Cell Stem Cell. The publication is available via this link.
This publication reports results from the first low-dose cohort (Cohort 1) of Luxa’s ongoing Phase 1/2a first-in-human clinical trial (NCT04627428) evaluating its proprietary RPESC-RPE-4W therapy. In Cohort 1, six participants received a subretinal injection of 50,000 RPESC-RPE-4W cells. Over the follow-up period, patients with severe vision loss gained an average of +21.67 ETDRS letters maintained through 12 months, representing the largest vision improvement reported to date in clinical trials of RPE cell therapies for dry AMD. Patients with better baseline vision showed more modest gains (+3.0 letters at 6 months). No tumor formation, severe inflammation, or therapy-related serious adverse events were observed.
“The results from Cohort 1 demonstrate the potential of RPESC-RPE-4W not only to restore vision in patients with severe vision loss, but also to benefit those at earlier stages of disease,” said Dr. Keith Dionne, CEO of Luxa Biotechnology. “We are excited to continue advancing our clinical program, which recently received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, as a potential new regenerative therapy for dry AMD, a leading cause of blindness with no currently approved vision-improving treatments.”
The article
