Ocata's Hemangio-derived Mesenchymal Cells Preserve Kidney Function and Extend Lifespan in Preclinical Model of Lupus Nephritis

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Ocata Therapeutics, Inc. OCAT, a leader in the field of regenerative medicine, reported in Scientific Reports ‒ a Nature Group journal ‒ that its proprietary hemangio-derived mesenchymal cell (HMC^TM) technology can be used to prevent the progression of fatal lupus nephritis in NZB/W F1 mice, a classic, well-studied spontaneous model for systemic lupus erythematosus (SLE).

"This study represents an important step in the development of a commercially scalable and efficacious cell therapy for lupus, a severe and debilitating autoimmune disease that has no cure and limited treatment options," said Robert Lanza, M.D., Chief Scientific Officer of Ocata. "We show, for the first time, that hESC-derived mesenchymal stem cells can alter lupus-associated glomerulonephritis and may serve as an alternative to primary tissue-derived stem cells. The cells prevented the progression of fatal lupus, and significantly reduced proteinuria and serum creatinine and preserved renal architecture."

SLE and lupus nephritis present significant disease management challenges. Current therapies are not curative and elicit adverse side-effects, particularly with long-term use. In addition, certain patient groups, such as those with kidney involvement, are often refractory to such treatments, highlighting the need to develop more effective therapies. The HMC product developed by Ocata has shown to have potent immune-modulatory and anti-inflammatory activity not only in SLE/LN, but also in several other autoimmune diseases.

"Our proprietary HMC platform could potentially be used to target significant autoimmune related disorders with high unmet needs such as Lupus Nephritis," said Dr. Paul Wotton PhD, President and CEO of Ocata. "HMCs are derived from a single and replenishable stem cell source that circumvents issues regarding scalability and consistent quality. Importantly, this technology could enable scalable manufacturing for global distribution of potent HMCs for off-the-shelf therapeutic use."

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 Ocata's belief regarding the potential therapeutic activity of a pluripotent stem cell-derived product in the treatment of auto immune diseases using Ocata's proprietary HMC platform, Ocata's belief that its HMC product is well-suited for commercial scale up and its retention of therapeutic potency, 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 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.

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