The company issued the following announcement this morning.
ACT and Roslin Cells Announce Collaboration for Storage and Distribution of Embryonic Stem Cells Using ACT’s Blastomere Technology
Embryonic Stem Cells Made Using ACT’s Patented Technique Soon To Be Available for Researchers and Companies Worldwide
MARLBOROUGH, Mass.– June 21, 2011 — Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it has entered into a definitive collaborative agreement with Roslin Cells LTD (“Roslin Cells”) of Scotland. The two companies will work together to establish a bank of Good Manufacturing Practice (GMP)-grade human embryonic stem cell (hESC) lines using ACT’s patented, proprietary “single-cell blastomere” technique for deriving hESC lines without destroying embryos. Stem cell lines from the resulting bank will be made available for both research and commercial purposes.
“This is a significant milestone in fulfilling our commitment to provide stem cells for clinical trials designed to help patients who are suffering from medical conditions for which there are no other options,” said Gary Rabin, ACT’s interim chairman and chief executive officer. “Embryonic stem cell research offers real promise for the treatment of a variety of currently incurable diseases and conditions. With the commencement of several clinical trials using hESC-based therapies, including the two for which ACT has been approved, the excitement on the part of both researchers and patients continues to grow. Our agreement with Roslin Cells is intended to address a number of practical and ethical issues facing the field, and should make it easier for researchers to explore the enormous potential of this exciting science for the future benefit of patients.”
Under the terms of the agreement, the hESC lines will be created and banked in compliance with the regulations of both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Roslin Cells will be responsible for maintaining the banked hESC lines, and it is anticipated that the banked hESC lines can be ushered expeditiously from laboratory settings directly into clinical programs, thereby speeding translational research. Roslin Cells will promote access to the hESC lines to both academic and commercial entities, and will establish a straightforward license which should enable third parties to have a predictable path to commercialization, at the time they choose to use the cells for discovery and preclinical research. ACT will continue to control any licenses to commercialization of products for the eye. ACT and Roslin Cells will share proceeds from these licenses, including milestone and royalty payments.
“Our aim is to provide researchers with access to hESC lines, which address many of the concerns which currently relate to research involving human embryonic stem cells,” commented Aidan Courtney, chief executive officer of Roslin Cells. “However, what is more exciting to us is the potential these hESCs hold with respect to their characteristics. Being derived from a point of earlier developmental potential, we anticipate that these single blastomere-derived ES cells will have broad plasticity and be ideally suited for use in the development and commercialization of regenerative medicine therapies. The collaboration with ACT will also accelerate our engagement with leading researchers in the US.”
ACT’s single-cell blastomere technique involves the isolation of a single cell from a 4-to-8 cell embryo, utilizing a one-cell biopsy approach similar to that used in pre-implantation genetic diagnostics (PGD). This single-cell biopsy is performed routinely around the world, and between one and two thousand children are born every year in the United States and Europe after being conceived by in vitro fertilization using this technique. ACT’s “blastomere” technique has been documented in Nature magazine, Cell Stem Cell, and elsewhere.
“There is considerable interest in using stem cell lines generated using our single-cell blastomere technique,” commented Robert Lanza, MD, ACT’s Chief Scientific Officer. “We are eagerly anticipating providing our cells to a variety of institutions through this arrangement with Rosin Cells.”
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.
About Roslin Cells
Roslin Cells Ltd was established in 2006 by the Roslin Institute with the support of the University of Edinburgh, the Scottish National Blood Transfusion Service and Scottish Enterprise. The company’s core mission is to provide ethically sourced, pluripotent human cells manufactured to the highest quality available according to Good Manufacturing Practice (GMP standards). Roslin Cells Quality Management System has been independently verified according to rigorous standards and successfully attained ISO 9001:2008 certification in February 2009 (Certificate Number: FS 544151). Since then, the company has continued to demonstrate their meticulous standards, with successful annual renewals of their Human Tissue Authority (HTA) and Human Fertilization and Embryology Authority (HFEA) licenses. Roslin Cells is headquartered in Roslin, Midlothian, Scotland, and is a not for profit organization.
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.
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