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September 19, 2013 at 09:48 AM EDT
ACT Files Investigational New Animal Drug (INAD) Application with FDA to Treat 10 Different Disease Indications Using Pluripotent Stem Cells

Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it has filed an Investigational New Animal Drug (INAD) application with the Food and Drug Administration (FDA) to test its proprietary “off-the-shelf” mesenchymal stem cells (MSC) in a range of different disease indications.

The studies will evaluate the safety and efficacy of ACT’s pluripotent stem cell-derived MSCs in ten spontaneous disease models in dogs, which are similar to various human inflammatory and immune-mediated diseases. While these companion animal studies represent research intended for ultimate licensure of veterinary therapeutics, ACT anticipates that the trial results may be relevant to its path to clinical trials in human patients and may provide a more robust assessment of safety and therapeutic endpoints than what can be obtained from inbred rodent models. The INAD is directed to ten canine disorders corresponding to hepatitis, glomerulonephritis, osteoarthritis, Crohn’s disease, inflammatory bowel disease, spinal cord/disc disease, meningoencephalitis, hemolytic anemia, pancreatitis and sepsis.

“This INAD filing extends our ongoing work with world experts in veterinary and regenerative medicine ,” said Robert Lanza, M.D., chief scientific officer of ACT. “Preliminary studies in rodents have shown that our hESC-derived MSCs possess unique biological and therapeutic properties, and can dramatically impact a spectrum of diseases ranging from lupus to multiple sclerosis. In addition to veterinary applications, these large animal studies may help inform and optimize subsequent human clinical trials that the company may pursue. We believe the etiology and system-wide effects of naturally-occurring diseases in large animals, such as dogs, provide an excellent model of human conditions.”

ACT’s proprietary MSCs have been extensively characterized both in vivo and in vitro, and their effects have been shown to be superior in animals to those of their bone marrow (BM)-derived MSCs counterparts. ACT’s proprietary MSCs are immunoprivileged and therefore, may be used “off the shelf” in a wide range of clinical indications. In addition to increased efficacy, hESC-MSCs can be expanded to large numbers in vitro (approximately 30,000 times greater yields per unit than adult BM sources). Since MSCs are derived from an inexhaustible starting stem cell line, the cost and regulatory burden of requiring many donors is thereby removed, as is the case with the adult sources of MSCs currently in the clinic. Having a single, donor-less source of pluripotent stem cells for manufacturing MSCs also removes the batch-to-batch variability in potency and the risk of communicable diseases that comes with relying on bone marrow or other adult tissue donors in the current MSC setting.

“The preclinical studies that Dr. Lanza and our team have carried out can now be translated into companion animal studies and, hopefully, human clinical studies in the not-too-distant future,” said Gary Rabin, Chairman and CEO of ACT. “In addition to advancing our corporate strategy to apply our cutting edge stem cell technologies to bring human therapies to market, this step into companion animals also elucidates new potential market opportunities for our company. The veterinary market is a large and exciting market in which we may have a significant opportunity to apply our leadership in regenerative medicine. The development of these therapies may permit veterinarians and pet owners to manage pets’ medical needs safely and effectively, and could result in longer and improved quality of life for pets.”

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, the relevance and applicability of clinical trials in animals to studying the effect of products in humans, future growth in animal and human research and development programs, potential new applications of and expanded indications covering our technology, the effects of donorless sources of stem cells on potency and the risk of communicable diseases in the manufacturing context, the existence and size of potential or existing market opportunities for the company, the effect of the company’s products on the medical needs and quality of life of pets, and any other statements about the future expectations, beliefs, goals, plans, 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: limited operating history, need for and limited sources of future capital, 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, protection of our intellectual property, 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 the company’s periodic reports, including the Quarterly Report on Form 10-Q for the three months ended June 30, 2013. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company 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 the company’s management at the time they are made, and the company 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 the Company’s clinical trials will be successful.


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