MARLBOROUGH, Mass.– Ocata Therapeutics, Inc. (NASDAQ:OCAT), a leader in the field of Regenerative Ophthalmology™, today announced that the first patient has been enrolled in the company’s Phase 2 clinical trial using Ocata’s proprietary RPE cells in patients with atrophic (dry) age-related macular degeneration (AMD).
The purpose of the trial is to evaluate safety and explore efficacy as compared to a parallel control group. Interim top-line results from the first cohort is expected in the second quarter of 2016 and the interim read-out on the second two cohorts is expected by the end of 2016.
Age-related macular degeneration is the leading cause of vision loss in people over the age of 50. Every year in the United States there are an estimated 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.
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.
We expect this Phase 2 clinical study will provide important information about the ability of Ocata’s fully differentiated RPE cells to treat dry age-related macular degeneration, when transplanted into the retina,” commented Carl D. Regillo, MD, FACS, Director, Retina Service at Wills Eye Hospital and Professor of Ophthalmology, Jefferson Medical College.
We are pleased to be a participating site in this clinical trial, as we believe that Ocata’s RPE program has the potential to be an effective treatment option for dry AMD, as well as other ophthalmological indications, such as Stargardt’s Disease.”
This Phase 2 study will include up to three cohorts of up to 20 subjects each. Each of the cohorts will receive one week of immune suppressive therapy prior to surgery and then different immune suppression regimens following transplantation of the cells, to determine the safety and tolerability of 0, 6 and 12 weeks of post-transplant systemic immune suppression. Untreated patients will receive placebo treatment similar in appearance and administration to those who have received cellular transplants.
“A key goal of this study is to more fully explore the efficacy signal that we reported in the Lancet in October of last year, with comparison to a control group of untreated patients rather than using the fellow eye for comparison. We believe that the data developed in this Phase 2 study will allow us to optimize the addressable patient population using well-controlled data while assessing potential endpoints for efficacy,” said Eddy Anglade, M.D., Chief Medical Officer of Ocata.
“We look forward to advancing into this next phase of development and we are grateful to the physicians and the patients who partner with us on these important programs. We expect that the data produced by this study will provide valuable guidance for the design of a Phase 3 program and could ultimately inform our commercial strategies.”
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 http://www.ocata.com.
All statements, other than historical facts, contained in this news release, including statements regarding Ocata’s belief regarding the continued clinical and commercial development of its RPE programs, the expected timing of the completion of its Phase 2 AMD clinical trial and each cohort as well as related top-line results and interim read-outs, the ability to optimize the addressable patient populations and otherwise further advance the RPE programs based on the data from this trial, the effect of such data on its potential commercial strategy, 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 or commercialization plans; 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 its 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.
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Ocata Therapeutics, Inc.
John Woolford, 443-213-0506