Ocata Therapeutics Receives Advanced Therapy Medicinal Product Designation from the European Medicines Agency
Advanced Medicinal Product Designation Granted for its Retinal Pigment Epithelium Programs, in clinical trials for Stargardt’s Macular Degeneration (SMD) and dry Age-related Macular Degeneration (AMD)
11/24/2014
MARLBOROUGH, Mass.-- Ocata Therapeutics, Inc., (OTCBB:OCAT) today announced that it has been granted Advanced Therapy Medicinal Product (ATMP) designation for its RPE therapy for macular degeneration. This designation is an essential step in allowing companies to commercialize products effectively across the European Union.
Dr. Eddy Anglade, Chief Medical Officer of Ocata Therapeutics, said: “We are pleased to receive ATMP status from the EMA. We view this as an important step to further enable the development of our novel biological therapy in the EU with the aim of seeking marketing authorization approval. Additionally, we interpret this as a favorable indication for how the European regulators view our therapy.”
Dr. Paul Wotton, President and Chief Executive Officer of Ocata Therapeutics, commented: “This milestone is particularly timely as we prepare to dose our first patient in the Phase 2 trial for Stargardt's patients by the end of this year. Last month The Lancet published results from our Phase 1/2 studies. The positive safety data along with signals of visual improvement realized by many of our patients, gives us great confidence to move forward with this important therapy. There are currently no approved treatments for either SMD, an orphan condition or dry AMD, both of which result frequently in devastating vision loss. We are committed to advancing our programs through clinical trials and to ultimately delivering them to patients in need.”
About Ocata Therapeutics, Inc.
Ocata Therapeutics, Inc. is a clinical stage biotechnology company focused on the development and commercialization of regenerative ophthalmology therapeutics. Ocata’s most advanced products are in clinical trials for the treatment of Stargardt’s macular degeneration, dry age-related macular degeneration, and myopic macular degeneration. Ocata’s intellectual property portfolio includes pluripotent stem cell platforms – hESC and induced pluripotent stem cell (iPSC) – and other cell therapy research programs. For more information, visit www.ocata.com.
About ATMP Classification: The aim of the ATMP classification is to regulate cell and gene therapy and tissue-regulated medicinal products. The European regulation provides guidelines to developers for non-clinical and manufacturing development as well as product quality testing. The regulation also offers incentives to companies involved in developing ATMP’s in the European Union, including fee reductions for scientific advice, scientific recommendations on ATMP classification and evaluation and certification of quality and non-clinical data.
