MARLBOROUGH, Mass. – March 23, 2011 – Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that China’s State Intellectual Property Office (SIPO) has allowed the Company’s patent application to provide broad intellectual property protection in China for the manufacturing and pharmaceutical preparations of retinal pigment epithelial (RPE) cells from human embryonic stem cells (hESCs).
This Chinese patent filing provides coverage of the scalable manufacturing of human RPE cells from hESCs. The claims cover methods for producing purified preparations of RPE cells from hESCs, and the use of those hESC-derived RPE cells in pharmaceutical preparations and compositions.
“The fact that we are being awarded a set of broad claims in China, following the issuance of the three far-reaching RPE patents in the U.S. last year, gives us greater confidence that we are in a position to create a dominant patent position around our stem cell-derived RPE program in leading markets around the world,” said Gary Rabin, ACT’s interim chairman and CEO. “Our progress in obtaining patent protection in China for our RPE program is a testament to the continued recognition of the inventions and innovations resulting from our scientific team’s ongoing research, and further protects the platform technology underlying one of our key therapeutic programs.”
The efficient production of highly pure RPE cell preparations derived from human embryonic stem cells represents the first critical step in the creation of a renewable source of transplantable cells that can be used to target macular degenerative diseases such as Stargardt’s Macular Dystrophy (SMD) and Dry Age-related Macular Degeneration (Dry AMD). The Company has already demonstrated that its hESC-derived RPE cells can rescue visual function in animal models of macular degeneration. At the end of 2010, ACT received clearance from the United States Food and Drug Administration (FDA) for two of its Investigational New Drug (IND) applications to initiate multicenter clinical trials using hESC-derived RPE cells to treat patients with SMD in one case (a common form of juvenile macular degeneration) and to treat Dry AMD in the other. The claims allowed by SIPO are similar to those the Company received as part of U.S. Patent Number 7736896, issued last June.
“This IP issuance is a particularly valuable step forward for us in Asia, as it could facilitate partnering and licensing arrangements,” added Mr. Rabin. “China is predicted to become the third-largest pharmaceutical market in the world later this year, and is an essential part of our global strategy. This patent allowance is an indicator of what we hope to achieve in the IP realm in Europe and elsewhere.”
*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 www.advancedcell.com.
Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company 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 future capital, risks inherent in the development and commercialization of potential 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 report on Form 10-K for the year ended December 31, 2010. 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.
James Young, 212-732-4300
ACT Corporate Communications
Bill Douglass, 646-450-3615
Martina Schwarzkopf, Ph.D., 212-845-4292