| Ocata Therapeutics Receives Regulatory Guidance from European Medicines Agency | Pivotal Clinical Trial Program Design for Stargardt's Macular Degeneration
MARLBOROUGH, Mass.--(BUSINESS WIRE)--March 17, 2015--
Ocata Therapeutics, Inc. ("Ocata"; NASDAQ: OCAT), a leader in the field of regenerative ophthalmology, today announced that the company has received written formal guidance from the European Medicines Agency (EMA) related to the advancement of its Retinal Pigment Epithelium Program (RPE) into a pivotal clinical trial for Stargardt's Macular Degeneration (SMD).
"We are pleased with the guidance we've received from the European Medicines Agency which means that our SMD program can be initiated as a pivotal clinical trial, potentially allowing us to apply for marketing authorization upon its completion," said Paul K. Wotton, President and Chief Executive Officer of Ocata Therapeutics who added, "As a result of these discussions we plan to enroll a total of approximately 100 patients, including an untreated control arm to more closely match guidance received from FDA. This would harmonize the development approach resulting in a more effective program."
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.
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 Age-related Macular Degeneration
Age-related macular degeneration is the leading cause of vision loss in people over the age of 50. Every year in the USA there are 1.8 million patients newly diagnosed with dry AMD which occurs when light-sensitive photoreceptor cells in the macula, located in the center of the retina, slowly break down, causing vision loss as a result. Photoreceptor breakdown is a consequence of loss or damage to the RPE layer. As the disease progresses, patients may have difficulty reading and recognizing faces. There is currently no proven medical therapy for dry AMD and the projected number of people worldwide with age-related macular degeneration in 2020 is 196 million, increasing to 288 million in 2040 underscoring the urgent need for new treatments.
About Stargardt's Disease
Stargardt's macular degeneration is a form of juvenile macular degeneration that affects vision in children and young adults between the ages of six and 20, with a prevalence of approximately one in 10,000 people in the United States. It is an orphan disease and loss of vision is an inevitable aspect of SMD, with more than half of the patients experiencing vision loss in the range of 20/200-20/400. Like dry AMD, it occurs as a result of damage to the RPE layer and there are no treatments currently approved to prevent or slow the vision loss associated with SMD.
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