|Rumors swirl around Advanced Cell Technology (OTCBB:ACTC)|
|By Access Wire|
|Monday, 13 December 2010 15:02|
The move to allow the phase I/II clinical trial will make the company the second in the US to test a human stem cell type of treatment. The study will use retinal cells, which will be derived from human stem cells, to transplant in 12 patients in the advanced stages of Stargardt's disease. The company hopes to treat specific forms of Macular Degeneration and blindness by injecting embryonic stem cell derived RPE cells into the eyes of human patients.
Researchers at the company saw 100% improvement with no side effects for more than 220 days in animal models whose visual cells had been damaged.
Advanced Cell Technology has been actively seeking to seize the vast commercial opportunity in Age-Related Macular Degeneration, an incurable disease, which afflicts nearly 15 million Americans and represents a $25-30 billion worldwide market.
Among the only viable therapies for the condition currently on the market is LUCENTIS (ranibizumab injection), a prescription medicine developed and distributed by Genentech for the treatment of patients with Wet Age-Related Macular Degeneration (AMD) and Macular Edema. The drug is known to have side effects and although not common, LUCENTIS patients have had eye- and non–eye-related blood clots, heart attacks, strokes, and death.
The company is about to start two Phase I trials in the U.S., but William M. Caldwell, Chairman and CEO of Advanced Cell Technology said in two recent interviews that while the U.S. market has been their primary focus of attention, the rest of the 30 million patients who suffer from Dry Age-Related Macular Degeneration worldwide also demand the company's attention.
"As big as the market is, and the opportunity is here in the United States, the European community offers a similar opportunity," said Caldwell in an interview with Biomedreports last week. "And with the E.U. controlling the regulatory perspective for the various countries on the continent, we will be looking very hard at the opportunity to take both our Stargardt’s and Dry AMD programs over there. I’ve been spending some time over there trying to ascertain what the best way is to do it and where the best places are to initiate the trials as well as learning a little bit about the process of how to work through the regulatory situations over there."
In an audio interview released on Monday by Proactive Investors, whose news sites cover financial developments in the U.S., Canada, Australia, U.K., and China, Caldwell stated: "I think you can also be looking for us to be moving into Europe with both these programs. So I would be looking to watch as we announce what our plans are for Europe. We're working through that right now."
Company officials could not be reached for comments on the latest rumors, but have previously stated via prepared statements their intentions to apply for permission to begin clinical trials in Europe in the near future. Any development involving a European partnership with an established biotechnology or pharmaceutical partner not only makes sense, but would serve to further validate a new technology that is among the closest to proving the potential clinical value of embryonic stem cell research.
Geron Corporation (Nasdaq: GERN ) was the first company to receive United States Food and Drug Administration license to use its stem cells and technology to treat a patient with a spinal cord injury at Shepard Center in Atlanta, Georgia.