MARLBOROUGH, Mass.--(BUSINESS WIRE)--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.
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.
All statements, other than historical facts, contained in this news release, including statements regarding the relevance and applicability of clinical trials, potential new applications of and expanded indications covering Ocata’s technology, the effect of Ocata’s products on the medical needs and quality of life of study subjects or other patients, Ocata’s potential product pipeline and development efforts, and any other statements about Ocata’s future expectations, beliefs, goals, plans, results or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: the fact that Ocata has no product revenue and no products approved for marketing; Ocata’s limited operating history;, the need for and limited sources of future capital; potential failures or delays in obtaining regulatory approval of products; risks inherent in the development and commercialization of potential products; reliance on new and unproven technology in the development of products; the need to protect Ocata’s intellectual property; the challenges associated with conducting and enrolling clinical trials; the risk that the results of clinical trials may not support the Company’s product candidate claims; even if approved, the risk that physicians and patients may not accept or use Ocata’s products; Ocata’s reliance on third parties to conduct its clinical trials and to formulate and manufacture its product candidates; and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Ocata’s periodic reports, including the Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2014. Forward-looking statements are based on the beliefs, opinions, and expectations of Ocata’s management at the time they are made, and Ocata does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of Ocata’s management at the time they are made, and Ocata does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that Ocata’s future clinical trials will be successful or that the results of previous clinical studies will lead to commercialization or products or therapies.