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Advanced Cell Technology to receive EU orphan status for Startgardt's stem cell treament

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3.7 from 3 votes
Friday, March 11, 2011

Advanced Cell Technology (OTCBB:ACTC) said Thursday that EU regulatory authorities have recommended that the company's human embroynic stem cell treatment for Startgardt's disease be designated as an orphan medicinal product.

Orphan drug designation provides regulatory and financial incentives for companies to develop treatments for life-threatening, or chronically debilitating, rare conditions. In addition to a 10-year period of marketing exclusivity in the EU after product approval, the status also helps with scientific advice during development, as well as a reduction in certain fees associated with the approval process.

The European Medicines Agency's (EMA) positive opinion will now be passed on to the European Commission for adoption, which should follow in the coming weeks.

Advanced Cell Technology's treatment uses retinal pigment epithelial (RPE) cells derived from human embryonic stem cells to replace those RPE cells lost in patients with Startgardt's, a juvenile degenerative eye disease.

The EMA's positive recommendation for orphan status follows from the US FDA granting the program the same status last year. Currently, the company's US phase I/II trials for the RPE program are progressing as scheduled.

"There is currently no approved treatment for Stargardt’s disease, and we are working diligently to move this European trial forward as quickly as possible," said the company's interim chairman and CEO, Gary Rabin.

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Source: Proactiveinvestors
3.66666666667
3.7 from 3 votes
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