Advanced Cell Technology has received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application to initiate 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 and gives ACTC clearance to immediately proceed with human trials.
Initially, the ground-breaking trials will begin with twelve patients throughout several different world-class clinics in the United States. Several location targets have been identified already, with other possible locations to be given consideration as well. The main purpose of this first phase of human trials will be to determine the safety and tolerability of the retinal pigment epithelium cells following sub-retinal transplantation to patients with advanced Stargardt’s Macular Dystrophy.
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 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.
Advanced Cell Technology (ACTC.OB)is well-positioned as an industry leader in this category as competition is virtually non-existent in a market that represents approximately $30 billion worldwide. Given that the Company is poised to move in this area of research, has been previously been granted orphan drug status from the FDA for its RPE cells and has a team of world-renown scientists at its helm, it is very likely that Advanced Cell Technology will be falling on the radar of biotechnology traders from here forward. Shares have climbed over 50% in morning trading to $0.071; up from its previous close of $0.0455.
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This document is not and should not be construed as an offer to sell or the solicitation of an offer to purchase or subscribe for any investment. Andrew Klips (“the author”) has based this document on information obtained from sources he believes to be reliable, but which has not been independently verified; the author makes no guarantee, representation or warranty and accepts no responsibility or liability as to its accuracy or completeness. Expressions of opinion are those of the author only and are subject to change without notice. The author assumes no warranty, liability or guarantee for the current relevance, correctness or completeness of any information provided within this Report and will not be held liable for the consequence of reliance upon any opinion or statement contained herein or any omission. Furthermore, the author assumes no liability for any direct or indirect loss or damage or, in particular, for lost profit, which you may incur as a result of the use and existence of the information provided within this Report.
The author does not own shares of Advanced Cell Technology.
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