Advanced Cell Technology today announced U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application to commence a Phase I/II multicenter clinical trial using retinal cells derived from human embryonic stem cells to treat patients with Stargardt’s Macular Dystrophy (SMD). This newly announced decision removes the clinical hold that the FDA had placed on the trial.
The first-of-its-kind human trials will be a prospective, open-label study consisting of twelve patients that will initially be conducted to determine the safety and tolerability of the RPE (retinal pigment epithelium) cells following sub-retinal transplantation to patients with advanced Stargardt’s Macular Dystrophy. While other sites will be considered, Jules Stein Eye Institute at UCLA (headed by Dr. Steven Schwartz); the Casey Eye Institute in Portland, Oregon (headed by Dr. Peter Francis of the Oregon Health Sciences University); the University of Massachusetts Memorial Medical Center in Worcester, Massachusetts (headed by Dr. Shalesh Kaushal, Chair of the Department of Ophthalmology); and the New Jersey Medical School in Newark, New Jersey (headed by Dr. Marco Zarbin, Chair, Institute of Ophthalmology and Visual Science) are considered likely candidates at this point.
Stargardt’s Macular Dystrophy is one of the most common forms of juvenile macular degeneration in the world today which causes progressive vision loss, typically in children between 10 and 20 years of age, inevitably ending in blindness as a result of photoreceptor loss related to the pigmented layer of the retina. As many as thirty million people in the United States and Europe suffer from macular degeneration. Approximately 10% of people aged 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.
To quote Dr. Robert Lanza, Advanced Cell Technology’s Chief Scientific Officer, “There is currently no treatment for Stargardt’s disease. Using stem cells, we can generate a virtually unlimited supply of healthy RPE cells, which are the first cells to die off in SMD and other forms of macular degeneration. We’ve tested these cells in animal models of eye disease. In rats, we’ve seen 100% improvement in visual performance over untreated animals without any adverse effects. Our studies showed that the cells were capable of extensive rescue of photoreceptors in animals that otherwise would have gone blind. Near-normal function was also achieved in a mouse model of Stargardt’s disease. We hope to see a similar benefit in patients with various forms of macular degeneration.”
From an investment standpoint, this new approval opens the doors to unlimited potential. Advanced Cell Technology is a clear leader in this industry, which represents a $25-30 billion worldwide market that has yet to be effectively addressed. This fact should be coupled with, amongst other things, two considerable factors. First, Advanced Cell collaborates with Dr. Raymond Lund, who is widely considered to be one of the world’s foremost experts in retinal cell physiology and vision restoration. Secondly, the FDA granted Orphan Drug designation for Advanced Cell’s RPE cells. An important component of this designation is that the Company is now eligible to receive several benefits including tax credits, access to grant funding for additional clinical trials, allowance for marketing exclusivity for up to seven years and consideration for accelerated FDA approval.
With all of these factors coming to light with this new announcement of ground-breaking human trials in the area of macular degeneration, investors are becoming quickly aware of this stock that is trading under a dime with very large upside potential.
With the news today, shares of ACTC have popped up 45.05% to $0.066 after hitting a high of $0.084 at the open on huge volume of over 40 million shares traded.
More information on Advanced Cell Technology can be found on the Company’s website at www.advancedcell.com
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