Nice coverage from our friends to the north, ehhh?? I especially like this part; "While research is still only in its infancy regarding human trials, there literally is no competition for Advanced Cell in this arena."
While the world of biotechnology has had more than its share of drama over the years, there is probably not a topic of conversation that has been more debated than stem cell research.
Whether it is over a coffee table, bar table, boardroom table, or a table surrounded by Senators and Governors in Washington, D.C., the battle has waged on over ethics, finances and legality, especially when it comes to the use of embryonic stem cells.
Last year, all of us witnessed history as Geron Corporation (Nasdaq:GERN) became the first company to ever receive United States Food and Drug Administration clearance to proceed with clinical trials using human embryonic stem cells. In the case of Geron, the research is focused on victims of spinal cord injuries.
At the end of November 2010, a much smaller company, Worcester, Massachusetts-based Advanced Cell Technology (OTCBB:ACTC) followed suit to become the second company in history to receive FDA clearance to commence Phase I/II human trials using human embryonic stem cells (hESCs). For Advanced Cell, the focus will be on Stargardt’s Macular Dystrophy, the most common and severe form of inherited juvenile macular degeneration, which typically begins in late childhood, generally leading to legal blindness.
Yesterday, Advanced Cell took another major leap forward in the growth of the company as it established itself as an elite, major presence within the industry by receiving its second of the three total approvals from the FDA to proceed with Phase I/II clinical trials using hESCs; this time as a therapy for Dry Age-Related Macular Degeneration (Dry AMD).
Dry AMD is a disease that destroys a person’s sharp, central vision by killing cells in the macula, the part of the eye that allows sight of fine detail. Dry AMD is the leading cause of legal blindness in persons over the age of 55 as what starts as blurry vision leads to a large black hole in sight as the disease progresses.
There are two main versions of macular degeneration, Dry AMD and Wet AMD. Wet AMD, which is far less prominent, only affecting about 15% of those suffering from AMD, has several therapies to treat the disease, while Dry AMD, which affects approximately 25 million people between the U.S. and Europe alone, has no therapies currently available.
For mankind, this research offers some incredible possibilities as pre-clinical research has brought forth very promising results for Advanced Cell with a high percentage of success being achieved in animal studies.
For investors, the magnitude of potential is something that is not often seen. Blockbuster drugs can generate billions in revenues year in and year out and this sort of therapy rivals that potential, if not exceeding it.
While research is still only in its infancy regarding human trials, there literally is no competition for Advanced Cell in this arena, which is intensifying the attention that Advanced Cell is now receiving on a daily basis. The share price has gone four-fold since the first announcement of FDA clearance, but is still only trading in the area of 20 cents, leaving a great deal of room for advancement as ongoing developments will continue to be in the limelight of the investment community.
Owning two-thirds of FDA approvals for clinical research using embryonic stem cells is certainly a major milestone that no company will probably ever achieve. Whether ACTC was riding under the radar of many investors or the biotechnology industry in the past, one thing is for sure: those days are behind the Company now.