MARLBOROUGH, Mass.--(BUSINESS WIRE)--Ocata Therapeutics, Inc. (“Ocata” or “the Company”; NASDAQ: OCAT), a leader in the field of Regenerative Ophthalmology™, announced today that data will be presented in a Late Breaking Abstract at the International Society for Stem Cell Research (ISSCR) 13th Annual Meeting being held in Stockholm, Sweden, June 24-27.
The presentation will provide a follow-up of four prospective safety trials carried out in the United States and also in South Korea. The results of these trials in 31 patients with dry Age-related Macular Degeneration (AMD) and Stargardt’s Macular Dystrophy (SMD) provide additional evidence supporting the safety and tolerability of hESC-derived retinal pigment epithelium (RPE). Some patients were followed for up to 4 years and none of the patients showed evidence of hyperproliferation, rejection or serious adverse ocular or systemic safety issues related to the transplanted tissue.
The abstract reported that all of the patients, 26 from the US studies and 5 from the South Korean study, experienced improved or stable, best-corrected visual acuity (BCVA). These studies suggest that hESC-derived cells could provide a potentially safe new source of cells for regenerative medicine.
“This late breaking abstract presented at the leading stem cell meeting is indicative of the significance and importance of our new potential breakthrough treatments for these disabling diseases where there is no cure available today,” said Paul K. Wotton, Ph.D., President and Chief Executive Officer. “We now look forward to the planned initiation of our Phase 2 safety study in dry AMD and our pivotal study in SMD.”
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.
Forward-Looking Statements
All statements, other than historical facts, contained in this news release, including statements regarding, Ocata’s belief that updated data presented at this conference are indicative of the efficacy of its product candidates and the ultimate results for its planned trials, Ocata’s belief that hESC-derived cells could provide a potentially safe new source of cells for regenerative medicine, the planned objective, endpoints and initiation of the Ocata’s clinical trial, 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; Ocata’s 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 Ocata’s product candidate claims; the risk that physicians and patients may not accept or use Ocata’s products, even if approved; 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 Annual Report on Form 10-K for the fiscal year ended December 31, 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.