GM Goats Make Anti-clotting Drug in Their Milk

FDA approval is pending Saturday, 10 January 2009 An anti-clotting drug made from the milk of genetically engineered goats moved closer to government approval Wednesday after experts at the Food and Drug Administration reported that the medication works and its safety is acceptable. Company data showed the drug was safe and effective, a majority of the Food and Drug Administration's 19-member panel voted. The FDA will consider the advice in making its decision, expected by February 7. Called ATryn, the drug is intended to help people with a rare hereditary disorder that makes them vulnerable to life-threatening blood clots. A Massachusetts biotechnology company, GTC Biotherapeutics, developed ATryn by altering the genes of goats so they would produce milk rich in human antithrombin, a protein that in humans acts as a natural blood thinner. Scientists at the GTC have made the drug by inserting the human antithrombin protein into single cell embryos of goats. These embryos were then put into the wombs of surrogate mothers who produced goats that possessed the new characteristics. The protein is gathered from the milk of the goat, which is then refined and purified. The scientific advisors at the FDA will see into the pros and cons of ATryn. They will then make a further recommendation for approval of the drug. “It's the first time we've held an advisory committee meeting on any product from a genetically engineered animal,” FDA spokeswoman Siobhan DeLancey said. If the drug is approved, then this would be a significant leap in the area of making medicines by altering genes of living organisms. GTC Biotherapeutics says that a single goat will produce more than six pounds of the protein in the course of a year, and also notes that the drug-producing trait will be naturally passed down to the next generation of goats. The company has a herd of about 200 at its Massachusetts facility, which are otherwise normal and screened for viruses, GTC said. “The real dramatic thing that is happening here is that we've been able to reduce some very clever science to the practical level of producing a drug that's safe and efficacious,” said Geoffrey Cox, Chairman GTC. The drug is licensed to Ovation Pharmaceuticals Inc in the United States. ......... ZenMaster

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For more on stem cells and cloning, go to CellNEWS at http://cellnews-blog.blogspot.com/ and http://www.geocities.com/giantfideli/index.html

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