Ocata Therapeutics Successfully Completes Dosing in Phase 1/2 RPE Studies

Ocata Therapeutics, Inc. ("Ocata"; NASDAQ:OCAT), a leader in the field of regenerative ophthalmology, today announced that the company has completed dosing of its Phase 1/2 studies for dry age-related macular degeneration (AMD) and Stargardt's Macular Degeneration (SMD). A total of 38 patients have been safely dosed. The 200,000 cell cohort, the highest level planned was successfully completed, paving the way for the next phase of the programs. "With successful completion of dosing for the phase 1/2 studies at the highest dose level, and following safety data review by the Data and Safety Monitoring Board, we are now able to focus on initiation and execution of our Phase 2 study for AMD and our pivotal study for SMD," said Paul K. Wotton, President and Chief Executive Officer of Ocata Therapeutics, who added, "We believe that data from the AMD studies will also be an important inflection point for the entire retinal pigment epithelium (RPE) program. As we have previously announced, we have received guidance from the European Medicines Agency indicating that our SMD program can be initiated as a pivotal clinical trial." The objective of the SMD trial will be to assess the safety and efficacy of subretinal transplantation of RPE cells compared to an untreated control group. The endpoints of the trial include functional and anatomic outcome parameters. The AMD trial will evaluate the safety of different regimens of immunosuppressive therapy while exploring functional and anatomic efficacy outcome parameters. Ocata previously announced that it has been granted Advanced Therapy Medicinal Product (ATMP) designation for its RPE therapy for macular degeneration. The SMD program has orphan status both in Europe and the US.