MARLBOROUGH, Mass.--(BUSINESS WIRE)--Ocata Therapeutics, Inc. (“Ocata” or “the Company”; NASDAQ: OCAT), a leader in the field of Regenerative Ophthalmology™, today announced that it has entered into a definitive agreement with Allele Biotechnology & Pharmaceuticals, Inc. of San Diego, CA (“Allele”) to access Allele’s proprietary technology for generating human induced pluripotent stem cells (“iPSCs”).
"This agreement with Allele is part of our strategy to broaden our technology platform and increase our leadership in regenerative ophthalmology,” said Paul Wotton Ph.D., President and CEO of Ocata. “Ocata can now take advantage of induced and embryonic pluripotent stem cells to produce commercially viable human tissue for transplantation. We recently confirmed proof of concept in creating photoreceptors capable of preventing blindness and restoring vision in established animal models. Data from these studies will be published later this year.”
Since Dr. Yamanaka discovered how to generate iPSCs in 2007 there has been tremendous enthusiasm about the potential to use these pluripotent cells to develop commercially viable therapies. Despite many efforts to develop iPSC derived therapies in the same scalable and reliable way as embryonic stem cells, many of those efforts have been unsuccessful due to issues relating to the growth capacity, differentiation potentials and epigenetic properties of iPSCs. The “footprint-free” reprogramming technology developed by Allele potentially offers a reliable and scalable process for producing iPSCs with superior properties and is a major step for translation of iPSC technology to practical clinical use. These iPSCs can potentially be used to manufacture millions of treatment doses as off-the-shelf therapies for any patient.
“We have had a strong leadership role in this area,” said Robert Lanza, M.D., Chief Scientific Officer of Ocata. “Ocata has extensive experience and patent rights in generating both ocular and non-ocular cell types from human iPSCs. We have painstakingly and patiently evaluated many different iPSC technologies and selected the Allele technology only after we were satisfied and confident that this represented the best of all approaches and could permit us to generate transplantable tissues that would be potentially safe in human patients. In our hands, the iPSCs we are generating are comparable to our embryonic stem cells in those features required for use in potential human therapies.”
“It is particularly rewarding to us that Ocata, a company whose understanding of the science and regulatory requirements in this space is unparalleled, has selected the iPSC technology developed at Allele for application in its own pipeline,” said Jiwu Wang Ph.D., President and CEO of Allele. “It only serves to confirm our belief that our iPSC platform is a solution to what otherwise have been unresolved issues associated with the maturation of iPSCs to a fully functional state. The ability to predictably derive stable iPSC lines without using any viral element or foreign DNA enables both fundamental scientific research and clinical applications, which has been the mission of Allele Biotechnology from its inception.”
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.
Forward-Looking Statements
All statements, other than historical facts, contained in this news release, including statements regarding the , the timing and substance of data related to in creating photoreceptors capable of preventing blindness and restoring vision in established animal models, the potential scalability and application of Allele’s iPSC technology licensed to us, including generation of transplantable tissues safe for human patients, 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.