MARLBOROUGH, Mass.--(BUSINESS WIRE)--Ocata Therapeutics, Inc. (NASDAQ:OCAT), a leader in the field of Regenerative Ophthalmology™, today announced that it has been awarded a Small Business Innovation Research (SBIR) Phase 1 grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to fund further preclinical development of Ocata’s proprietary Hemangio-derived Mesenchymal Cell (HMC™) product for the treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN).
“Ocata has demonstrated potential therapeutic activity of a pluripotent stem cell-derived product for the treatment of autoimmune diseases such as lupus nephritis and Crohn's disease,” said Robert Lanza, M.D., Chief Scientific Officer at Ocata, and Principle Investigator of the grant. “Our studies in highly regarded pre-clinical models of lupus nephritis provided proof of concept that our HMC’s increased the lifespan of the lupus-prone mice and inhibited the progression of otherwise fatal glomerulonephritis.”
Systematic lupus erythematosus (SLE) is a systemic autoimmune disease that presents significant disease management challenges, as there is currently no known cure. While treatment to relieve symptoms is sometimes available for patients with mild to moderate SLE, a subset of SLE patients resist all forms of current interventions and develop LN, a severe and debilitating disease. The HMC product developed by Ocata has shown to have immune-modulatory and anti-inflammatory activity to help treat these diseases.
“This grant from the NIH, a preeminent research agency, recognizes the promise of our HMC product as a potential new treatment for disabling autoimmune diseases like lupus nephritis, where there is no cure available today,” said LeRoux Jooste, Chief Commercial Officer and SVP Business Development. “Our preclinical research and patent estate firmly anchors our leading position in the development of our novel Restorative Immunology™ platform and expands Ocata’s potential to partner the non-ophthalmic uses of its technology for the treatment of devastating autoimmune diseases.”
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.
All statements, other than historical facts, contained in this news release, including statements regarding Ocata’s belief regarding the continued development of its HMC product, the ability to produce and the potential effectiveness of a pluripotent stem cell-derived product to treat auto immune diseases, the effect of Ocata’s pre-clinical research and patent estate on the development of its product platforms, 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 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.