Much has already been written about Advanced Cell Technology over the last six weeks, but the news keeps pouring in about this company as it continues to produce historic announcements regarding its penetration into the field of embryonic stem cell research. History was made in 2010 as the U.S. Food and Drug Administration approved clearance for Geron (NASDAQ:GERN) and Advanced Cell Technology to proceed with human trials using embryonic stem cells; Geron for spinal cord injuries and Advanced Cell for Stargardt’s Macular Dystrophy. These were the only two clinical studies involving embryonic stem cells ever approved by the U.S. FDA…until now.
It was announced this morning that the Food and Drug Administration has approved Advanced Cell’s Investigational New Drug (IND) application to treat Dry Age-Related Macular Degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The Company is now permitted to initiate a Phase I/II multicenter clinical trial to treat patients with Dry AMD, the most common form of macular degeneration in the world, for which there are no current treatments available for this prevalent disease of an aging global population. In the United States alone, Dry AMD affects 10 to 15 million people. In Europe, it is estimated that over ten million people are afflicted with the disease.
Dry AMD, the leading cause of blindness in people over 55, occurs when the light-sensitive cells in the macula slowly break down, gradually blurring central vision in the affected eye. As dry AMD gets worse, a blurred spot in the center of the patient’s vision may occur. Over time, as less of the macula functions, central vision is gradually lost in the affected eye.
Much like the clinical trials for Stargardt’s Disease that Advanced Cell will be conducting, the Phase I/II trial for Dry AMD will be a prospective, open-label study that is designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with Dry AMD. Twelve patients will be enrolled in the study at multiple clinical sites. Although many sites may be considered, sites that are currently under consideration are the Jules Stein Eye Institute at UCLA and the Ophthalmology Department at Stanford University School of Medicine.
Many comments have been made on Advanced Cell Technology across the web as speculation runs rampant. As with any stock play, there are critics and those that play “Devil’s Advocate” to rebut the optimists. What cannot be questioned is that this is a saga about a company that will be unfolding for years to come. The Company presently controls two-thirds of the IND’s approved by the U.S. FDA and these represent an enormous area of unmet need worldwide. People can debate any of the details until their fingers cramp from typing, but the potential for revenues and human benefits are substantial, to say the least. Now, only time will tell how the rest plays out for the Company, ACTC shareholders and those who suffer from these terrible diseases.
More information on Advanced Cell Technology can be found on the Company’s website at www.advancedcell.com
More on the Dry AMD clinical trials including specific inclusion and exclusion requirements and investigator contact information will soon be posted at www.clinicaltrials.gov