Company Commences GLP Safety Studies with MPI Research for RPE Cells Manufactured under GMP Compliant Conditions
ALAMEDA, California-- (BUSINESS WIRE)" Advanced Cell Technology, Inc. (OTCBB:ACTC) today announced major advancements in the process of bringing its Retinal Pigment Epithelial (RPE) program into the clinic to treat various retinal degenerative diseases, including Age-Related Macular Degeneration (AMD). After preliminary discussions earlier this year with staff from the Office of Cellular, Tissue, and Gene Therapies within the Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA), the company has contracted with a leading contract research organization in order to commence work on an extensive preclinical program. Earlier this month, MPI Research, located in Mattawan, Michigan, initiated pilot studies under Good Laboratory Practices (GLP) for Advanced Cell Technology's (ACT) ongoing RPE program.
This study is the first of several that will provide substantial safety data for an Investigational New Drug (IND) application, necessary for the initiation of a clinical trial. Due to the complex nature of stem cell derived cellular therapies, these studies are original, unique, and state-of-the-art. The protocols utilize therapeutic dosage levels of RPE cells based on recent data obtained through pharmacological dosage studies in the RCS rat, a key animal model of retinal disease. For the preliminary GLP studies, the company is utilizing RPE cells that have been differentiated from human embryonic stem cells, under current Good Manufacturing Practice (cGMP) conditions in its Worcester, Massachusetts facility. Applying appropriate controls as specified in the FDA's cGMP regulations, ACT staff was able to produce master and working cell banks of human embryonic stem cells. In working out a controlled, compliant manufacturing methodology, an unlimited amount of RPE cells can be derived by ACT for clinical use.
ACT scientists have also developed novel methodology to cryopreserve the RPE cell product, thereby overcoming various clinical issues faced by other cell therapy companies. ACT is planning for further dialogue with the FDA, as well as additional safety testing and other innovative analyses of the RPE cell product. ACT believes the commencement of these studies with all the work that lead up to them represents a significant milestone towards the program's success and future clinical trial.
Pedro Huertas, M.D., Ph.D., Chief Development Officer of Advanced Cell Technology remarked, "This is an important step for us and a tribute to the efforts of our team in translating a scientific finding into a potential therapeutic application. We expect that the GLP studies will move us closer to the successful filing of an IND and to FDA regulated clinical trials of RPE cells to treat retinal degenerative diseases.�”
Mr. William M. Caldwell, IV, Chairman and CEO of ACTC commented, "I am very proud to announce the extensive work to date on the RPE program for our company. We remain steadfast in our commitment to drive our therapeutic programs to the clinical stage.”
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc. is a biotechnology company applying embryonic stem cell technology in the emerging field of regenerative medicine. The company operates facilities in Alameda, California and Worcester, Massachusetts.
About MPI Research
MPI Research, with headquarters in Mattawan, Michigan, is one of the worlds leading providers of comprehensive preclinical research and development services. More information on the company's services can be obtained through the website at www.mpiresearch.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-QSB for the quarter ended March 31, 2007. 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.
The Investor Relations Group
Investors: James Carbonara or Joseph Kessler, 212-825-3210
Media: Bill Douglass, 212-825-3210