ACT Announces UCLA Institutional Review Board (IRB) Approval of its Phase 1/2 Clinical Trials using hESC-Derived RPE Cells for the Treatment of Macular Degeneration - Yahoo! Finance
MARLBOROUGH, Mass., April 28, 2011 /PRNewswire/ -- Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Jules Stein Eye Institute at the University of California, Los Angeles (UCLA) has received institutional review board (IRB) approval to be a site for its Phase 1/2 human clinical trials for Stargardt's Macular Dystrophy (SMD) and Dry Age-Related Macular Degeneration (Dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).
"It is only appropriate that an institution with the global stature of UCLA's Jules Stein Eye Institute would be a site for the first-ever clinical trials using embryonic-derived stem cells to treat diseases of the eye, and we could not be more pleased," said Gary Rabin, interim chairman and CEO of ACT. "One of the world's foremost institutions for ophthalmology-related clinical trials, the institute represents an ideal partner for both trials, and we are eagerly anticipating starting them as soon as possible."
The Phase 1/2 trials will be prospective, open-label studies designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with SMD and Dry AMD.
"The outstanding scientific and leadership teams at ACT are extremely impressive. Together, our collaboration has led to both FDA and IRB permission to commence these trials. This signals the long-awaited societal and institutional 'green light' to take what will hopefully be a huge step forward into the realm of human stem cell science. I am honored to be leading the clinical collaboration," said Steven Schwartz, MD, Ahmanson Professor and Retina Division Chief, at UCLA's Jules Stein Eye Institute and Principal Investigator of the trials.
Enrollment criteria for patient selection will be posted at Home - ClinicalTrials.gov in coming days.
About Dry AMD and SMD
Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. As many as thirty million people in the United States and Europe suffer from macular degeneration, which represents a $25-30 billion worldwide market that has yet to be effectively addressed.
Approximately 10% of people ages 66 to 74 will have symptoms of macular degeneration, the vast majority the "dry" form of AMD – which is currently untreatable. The prevalence increases to 30% in patients 75 to 85 years of age.
Stargardt's Macular Dystrophy (SMD) is one of the most common forms of macular degeneration in the world. SMD causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium or RPE cell layer.
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 Advanced Cell Technology.
About the Jules Stein Eye Institute
Established in 1966, the Jules Stein Eye Institute represents the culmination of a dream shared by ophthalmologist, businessman and philanthropist Dr. Jules Stein and his wife Doris, of creating a world-renowned center dedicated to the preservation of vision and the prevention of blindness. The Institute's comprehensive programs for the care of patients with eye disorders, research in the vision sciences, education in the field of ophthalmology and outreach to the community, coupled with its state-of-the art facilities, have brought national and international recognition to the Institute and UCLA. Many have contributed to this tradition of excellence and many more will carry it forward as the Institute continues its mission to advance ophthalmology worldwide.
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-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
