Advanced Cell Technology Announces Completion Of Pre-IND Meeting With The FDA For RPE Therapy For The Treatment Of Retinal Degenerative Disease
Studies of the company's proprietary RPE cells have shown that the therapy may ultimately provide effective treatment of degenerative retinal disorders including macular degeneration, which represents a $28 billion dollar market. AMD affects more than 30 million people worldwide and is the leading cause of blindness in people over 60 in the United States. The prevalence of AMD begins to increase after the age of 50. Approximately 15% of people over 75 have the condition. To date, AMD patients have had few if any effective therapies for treatment; thus, the need for novel therapies is clear.
In November at Neuroscience 2007, researchers at Oregon Health and Science University (OHSU) presented results of a study that used ACT RPE cells manufactured under GMP conditions (21CFR211) at the company's facility in Worcester, Massachusetts. The RPE cells were thoroughly characterized and cryo-preserved and shipped to researchers at OHSU for transplantation. The conclusions drawn by researchers were that visual function can be rescued and preserved in this animal model of disease utilizing ACT's GMP-manufactured human ES-derived RPE cells with a functional dose threshold and that these cells may provide an effective donor cell source to rescue photoreceptors in conditions like AMD, where RPE function is compromised.
The next step in the development of the program will be to complete several safety studies utilizing the GMP-manufactured RPE cells. Pilot studies to date have shown the cells to be safe, well tolerated, and non-migratory. The Good Laboratory Practice (GLP) compliant studies are required prior to filing an IND. The safety studies will include several key areas of examination, including, tumorigenicity potential, cell tolerability, cell survival, general safety, and potential for biodistribution.
"We are pleased to complete this key milestone as we move our RPE program toward the clinic," said William Caldwell, IV, Chairman and CEO of Advanced Cell Technology. "Based upon our cell characterization data, pharmacology studies, and the overall safety profile, we are excited by the prospects for this program and the potential to treat a large unmet medical need. The successful completion of our Pre-IND meeting represents another step forward towards the filing of the IND for our RPE Program and ultimately bringing the therapy to the bedside. We are one step closer to bringing our second stem cell therapy to patients in need."
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.
Forward-Looking Statements
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 September 30, 2006. 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.
Advanced Cell Technology
Tehnologie avansatã de celule anunta finalizarea pre-ROM întâlnire cu FDA pentru RPE terapie pentru tratamentul bolilor degenerative retiniene - Advanced Cell Technology Announces Completion Of Pre-IND Meeting With The FDA For RPE Therapy For The Treatment Of Retinal Degenerative Disease - articole medicale engleza - startsanatate