ACTC.OB appreciated (+ $0.014) 15.73 % on 2/22/10, with 18.5 M shares traded … after the National Institutes of Health (NIH) stated (over the weekend) that it was slightly expanding its definition for what constitutes a human embryonic stem cell as acceptable lines for federal funding. This NEW proposal will benefit several academic researchers and ACTC.OB, that has filed a request with the FDA to test a treatment for macular degeneration, an eye disease. If approved, it would be among the 1st clinical tests of embryonic stem cells. NIH guidelines previously defined the cells as “derived from the inner cell mass of blastocyst stage human embryo.” As proposed in the Federal Register, the new definition will cover “early stage embryos up to and including the blastocyst stage“.
The NIH, in changing the definition, explicitly acknowledged that ACTC.OB’s application contributed to the decision. The ruling, which will have limited impact for the overall stem cell industry, carries broad implications for ACTC.OB.
- Essentially, the agency is re-writing its definition of what constitutes acceptable cell lines for federal funding to include its technology platform,
- ACTC.OB has previously submitted 5 different lines for approval to qualify for funding by the NIH,
- Once and if … the NIH’s proposed rule making is implemented, all of those lines could qualify for federal funding under the new definition,
- 1 of the lines submitted was derived from ACTC.OB’s single blastomere technology, which is the line of RPE cells that its Phase I/II multi-center study using embryonic stem cell derived retinal cells to treat patients with Stargardt’s Macular Dystrophy,
- This suggests that the trial might receive federal funding.
Nicholas Wade’s article in the NY Times; link: http://www.nytimes.com/2010/02/20/health/policy/20nih.html?hp